Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-04-10 @ 6:51 AM
Study NCT ID:
NCT03181451
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062088', 'term': 'ferric maltol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmitchell@shieldtx.com', 'phone': '+44 (0) 191 511 8515', 'title': 'Jackie Mitchell MA DPhil', 'organization': 'Shield Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '10 days', 'eventGroups': [{'id': 'EG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nevus haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Granuloma skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration [Cmax] of Maltol Glucuronide on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4518', 'spread': '1.29590', 'groupId': 'OG000'}, {'value': '1.1632', 'spread': '0.18435', 'groupId': 'OG001'}, {'value': '0.5299', 'spread': '0.02245', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration [Cmax] of Maltol Glucuronide on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2355', 'spread': '0.78110', 'groupId': 'OG000'}, {'value': '2.1028', 'spread': '0.13342', 'groupId': 'OG001'}, {'value': '0.9926', 'spread': '0.02349', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under The Curve [AUC] of Maltol Glucuronide on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.090', 'spread': '3.9033', 'groupId': 'OG000'}, {'value': '5.613', 'spread': '0.7589', 'groupId': 'OG001'}, {'value': '2.585', 'spread': '0.0968', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide AUC from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h*mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'type': 'PRIMARY', 'title': 'Area Under The Curve [AUC] of Maltol Glucuronide on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.511', 'spread': '1.7997', 'groupId': 'OG000'}, {'value': '10.518', 'spread': '0.5277', 'groupId': 'OG001'}, {'value': '5.016', 'spread': '0.1133', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol AUC from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h*mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'type': 'PRIMARY', 'title': 'Average Plasma Concentration [Cave(0-6h)] of Maltol Glucuronide on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4186', 'spread': '0.29995', 'groupId': 'OG000'}, {'value': '1.7531', 'spread': '0.08795', 'groupId': 'OG001'}, {'value': '0.8360', 'spread': '0.01889', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Cave(0-6h) from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Plasma Concentration [Tmax] of Maltol Glucuronide on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Plasma Concentration [Tmax] of Maltol Glucuronide on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '0.75'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '0.75'}, {'value': '0.75', 'groupId': 'OG002', 'lowerLimit': '0.75', 'upperLimit': '0.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'type': 'PRIMARY', 'title': 'Half Life [t1/2] of Maltol Glucuronide on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.384', 'spread': '5.4738', 'groupId': 'OG000'}, {'value': '10.447', 'spread': '1.8503', 'groupId': 'OG001'}, {'value': '10.806', 'spread': '0.4707', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide t1/2 from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'type': 'PRIMARY', 'title': 'Ratio of Maximum Plasma Concentration [Cmax] of Maltol Glucuronide on Day 10/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.956', 'spread': '0.6210', 'groupId': 'OG000'}, {'value': '1.836', 'spread': '0.2109', 'groupId': 'OG001'}, {'value': '1.875', 'spread': '0.0537', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 10, pre-dose and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics of ratio maltol glucuronide Cmax Day 10/Day 10 from PK samples collected on Day 1 and Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'type': 'PRIMARY', 'title': 'Ratio of Area Under The Curve [AUC] of Maltol Glucuronide on Day 10/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.030', 'spread': '0.6695', 'groupId': 'OG000'}, {'value': '1.899', 'spread': '0.2286', 'groupId': 'OG001'}, {'value': '1.942', 'spread': '0.0582', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 10, pre-dose and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics of ratio maltol glucuronide AUC Day 10/Day 10 from PK samples collected on Day 1 and Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Average Serum Concentration [Cave(0-6h)] of Iron on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1667', 'spread': '0.61420', 'groupId': 'OG000'}, {'value': '0.9557', 'spread': '0.29645', 'groupId': 'OG001'}, {'value': '0.9748', 'spread': '0.39783', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of iron Cave(0-6h) from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in Serum Iron on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6159', 'spread': '0.32320', 'groupId': 'OG000'}, {'value': '0.4102', 'spread': '0.22144', 'groupId': 'OG001'}, {'value': '0.21715', 'spread': '0.11873', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of change in serum iron \\[Ctrough to Cmax\\] from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in Serum Iron on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5486', 'spread': '0.32367', 'groupId': 'OG000'}, {'value': '0.3625', 'spread': '0.15333', 'groupId': 'OG001'}, {'value': '0.2251', 'spread': '0.08362', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of change in serum iron \\[Ctrough to Cmax\\] from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Serum Iron on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.711', 'spread': '2.5721', 'groupId': 'OG000'}, {'value': '5.963', 'spread': '1.7793', 'groupId': 'OG001'}, {'value': '3.928', 'spread': '1.1318', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h*mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Serum Iron on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.000', 'spread': '3.6852', 'groupId': 'OG000'}, {'value': '5.734', 'spread': '1.7787', 'groupId': 'OG001'}, {'value': '5.849', 'spread': '2.3870', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h*mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Transferrin Saturation (TSAT) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '179.47', 'spread': '60.259', 'groupId': 'OG000'}, {'value': '159.21', 'spread': '50.723', 'groupId': 'OG001'}, {'value': '104.50', 'spread': '41.009', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h*%', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Transferrin Saturation (TSAT) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '180.14', 'spread': '76.193', 'groupId': 'OG000'}, {'value': '149.40', 'spread': '37.799', 'groupId': 'OG001'}, {'value': '157.43', 'spread': '81.693', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h*%', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Systemic Clearance (CL/F) of Iron on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.321', 'spread': '0.6945', 'groupId': 'OG000'}, {'value': '0.654', 'spread': '0.2441', 'groupId': 'OG001'}, {'value': '0.324', 'spread': '0.1517', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 1', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Systemic Clearance (CL/F) of Iron on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.264', 'spread': '2.2297', 'groupId': 'OG000'}, {'value': '1.757', 'spread': '0.6673', 'groupId': 'OG001'}, {'value': '0.808', 'spread': '0.3089', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 10', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (V/F) of Iron on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.114', 'spread': '7.2315', 'groupId': 'OG000'}, {'value': '14.244', 'spread': '4.8083', 'groupId': 'OG001'}, {'value': '10.462', 'spread': '3.1033', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of iron V/F from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (V/F) of Transferrin Saturation (TSAT) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of TSAT V/F from PK samples collected on Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'As PPD analysis was performed, the V/F could not be estimated.'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (V/F) of Transferrin Saturation (TSAT) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of TSAT V/F from PK samples collected on Day 10', 'reportingStatus': 'POSTED', 'populationDescription': 'As PPD analysis was performed, the V/F could not be estimated.'}, {'type': 'PRIMARY', 'title': 'Ratio Auc(0-6) Maltol Glucuronide Day 10/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.942', 'spread': '0.0582', 'groupId': 'OG000'}, {'value': '1.899', 'spread': '0.2286', 'groupId': 'OG001'}, {'value': '2.030', 'spread': '0.6695', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Ratio AUC0-6h measured after last dose of Ferric Maltol on Day 10 vs first dose Day 1.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Serum Iron - RAUC(0-6h) D10/D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.529', 'spread': '1.4673', 'groupId': 'OG000'}, {'value': '1.020', 'spread': '0.3170', 'groupId': 'OG001'}, {'value': '1.038', 'spread': '0.3973', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured after first and last dose of Ferric Maltol on Day 1 & Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Serum Iron - RAUC(0-6h) Day 10/Day 1', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Transferrin Saturation (%) Day 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '9.25', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '9.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 1 (0h)', 'description': 'Transferrin Saturation (TSAT%) Day 1, baseline', 'unitOfMeasure': 'percentage saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Transferrin Saturation (%) Day 1, Maximum Response (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.68', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '28.261', 'spread': '8.4784', 'groupId': 'OG001'}, {'value': '32.845', 'spread': '10.5913', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 1 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Transferrin Saturation (TSAT%) Day 1, maximum response (%)', 'unitOfMeasure': 'percentage saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Transferrin Saturation Day 1, Time to Maximum Response Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 1. (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Transferrin Saturation (TSAT%) Day 1, time to maximum response Tmax (h). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Transferrin Saturation (%) Day 10, Maximum Response (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.779', 'spread': '13.863', 'groupId': 'OG000'}, {'value': '27.214', 'spread': '6.699', 'groupId': 'OG001'}, {'value': '33.524', 'spread': '13.633', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured after last dose of Ferric Maltol on Day 10. (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Transferrin Saturation (TSAT%) Day 10, maximum response (%). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'percentage saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Transferrin Saturation Day 10, Time to Maximum Response Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 10. (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h).', 'description': 'Transferrin Saturation (TSAT%) Day 1, time to maximum response Tmax (h). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'AUC0-inf Day 1 for Maltol Glucuronide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.590', 'spread': '0.2025', 'groupId': 'OG000'}, {'value': '17.862', 'spread': '0.9328', 'groupId': 'OG001'}, {'value': '34.372', 'spread': '4.5052', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 1 (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'AUC0-inf for Maltol Glucuronide from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'h.mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'AUC0-tau Day 10 for Maltol Glucuronide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.59', 'spread': '0.2024', 'groupId': 'OG000'}, {'value': '17.862', 'spread': '0.9327', 'groupId': 'OG001'}, {'value': '34.368', 'spread': '4.4981', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured after last dose of Ferric Maltol on Day 10. (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'AUC0-tau for Maltol Glucuronide from PK samples collected on Day 10. Area under the plasma concentration versus time curve from time 0 to tau.', 'unitOfMeasure': 'h mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Cthrough for Maltol Glucuronide Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4804', 'spread': '0.01639', 'groupId': 'OG000'}, {'value': '0.9762', 'spread': '0.10586', 'groupId': 'OG001'}, {'value': '1.8496', 'spread': '0.67761', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 pre-dose to last (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Change from pre-dose to last PK samples collected on Day 10 for maltol glucuronide.Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT.'}, {'type': 'PRIMARY', 'title': 'Serum Iron Cmax Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7030', 'spread': '0.19765', 'groupId': 'OG000'}, {'value': '1.681', 'spread': '0.30405', 'groupId': 'OG001'}, {'value': '1.2328', 'spread': '0.47471', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Maximum serum concentration of serum iron on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Serum Iron Cmax on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0338', 'spread': '0.4023', 'groupId': 'OG000'}, {'value': '1.0462', 'spread': '0.3221', 'groupId': 'OG001'}, {'value': '1.3034', 'spread': '0.6741', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Maximum serum concentration of serum iron on Day 10.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Plasma Maltol Glucuronide Cthrough D10/Day1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4804', 'spread': '0.0163', 'groupId': 'OG000'}, {'value': '0.9762', 'spread': '0.105', 'groupId': 'OG001'}, {'value': '1.8496', 'spread': '0.677', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Minimum concentration between dose time and dose time+TAU', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Apparent Systemic Clearance (CL/F) of Transferrin Saturation (TSAT) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h', 'description': 'Descriptive statistics and population PK analysis of serum TSAT CL/F from PK samples collected on Day 1', 'reportingStatus': 'POSTED', 'populationDescription': 'As PPD analysis was performed the CL/F could not be estimated.'}, {'type': 'PRIMARY', 'title': 'Apparent Systemic Clearance (CL/F) of Transferrin Saturation (TSAT) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of serum TSAT CL/F from PK samples collected on Day 10', 'reportingStatus': 'POSTED', 'populationDescription': 'As PPD analysis was performed, the V/F could not be estimated.'}, {'type': 'SECONDARY', 'title': 'Transferrin - Change From Baseline to Day 10, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.085', 'spread': '0.1510', 'groupId': 'OG000'}, {'value': '-0.147', 'spread': '0.1419', 'groupId': 'OG001'}, {'value': '0.032', 'spread': '0.2275', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-dose to Day 10 pre-dose (0h on each day)', 'description': 'Change calculated as difference in values measured at Day 1, predose (Baseline) and on Day 10, predose', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only subjects who had baseline samples taken on each PK day.'}, {'type': 'SECONDARY', 'title': 'Ferritin - Change From Baseline to Day 10, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '8.22', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '3.73', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '4.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 1 to Day 10 (0h)', 'description': 'Change calculated as difference in values measured at Day 1, predose (Baseline) and on Day 10, predose.', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only subjects who had baseline samples taken on each PK day.'}, {'type': 'SECONDARY', 'title': 'Total Iron Binding Capacity - Change From Day 1 to Day 10, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.12', 'spread': '3.406', 'groupId': 'OG000'}, {'value': '-3.11', 'spread': '3.201', 'groupId': 'OG001'}, {'value': '1.13', 'spread': '4.452', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose from Day 1 to Day 10 (0h on each day)', 'description': 'Change calculated as difference in values measured at Day 1, predose and on Day 10, predose', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only subjects who had baseline samples taken on each PK day.'}, {'type': 'SECONDARY', 'title': 'UIBC - Change From Day 1 to Day 10, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.10', 'spread': '7.775', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '5.525', 'groupId': 'OG001'}, {'value': '-4.49', 'spread': '8.343', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 1 to Day 10 (0h each day)', 'description': 'Change calculated as difference in values measured at Day 1, predose and on Day 10, predose', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Negative and Positive NTBI Tests on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Negative', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (0h)', 'description': 'Negative and Positive Non-Transferrin Bound Iron \\[NTBI\\] tests on Day 1, predose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 10 in Haemoglobin Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.789', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '1.097', 'groupId': 'OG001'}, {'value': '-0.45', 'spread': '0.301', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Day 10 (1-4 hours post-dose)', 'description': 'Change calculated as difference in values measured at Screening (Baseline) and on Day 10', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 10 in Absolute Reticulocyte Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.036', 'spread': '0.0114', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.0218', 'groupId': 'OG001'}, {'value': '0.016', 'spread': '0.0358', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change calculated as difference in values measured at Screening (Baseline) and on Day 10.', 'description': 'Change from Baseline to Day 10 in Absolute Reticulocyte Count collected from PK samples', 'unitOfMeasure': 'cells*10^12/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only subjects who had baseline samples and Day 10 samples taken.'}, {'type': 'SECONDARY', 'title': 'Treatment-emergent Adverse Events (AEs) Leading to Premature Discontinuation of Study Drug/PK Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of Ferric Maltol on Day 1 through study completion, on average 4 weeks', 'description': 'Descriptive summary of incidence and causal relationship of treatment-emergent adverse events leading to discontinuation of study drug/PK assessments according to MedDRA preferred term (PT) and system organ class (SOC)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'screened population'}, {'type': 'SECONDARY', 'title': 'Changes in 12-lead ECG Parameters From Screening to Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'Abnormal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening and Day 10 (1-4 hours post-dose)', 'description': 'Overall clinical interpretation of routine ECG parameters from Screening to Day 10', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Subjects who had ECG performed at both visits.'}, {'type': 'SECONDARY', 'title': 'Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening, Day 1, Day 10 and Post-Study Follow-up visit, on average 4 weeks', 'description': 'Number of subjects with concomitant medications Taken by \\>5% of Subjects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Negative and Positive NTBI Tests on Day 10, Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Negative', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 10', 'description': 'Negative and Positive Non-Transferrin Bound Iron \\[NTBI\\] tests on Day 10, predose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Treatment-emergent Serious Adverse Event (TESAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of ferric maltol Day 1 through study completions, on average 4 weeks', 'description': 'Descriptive summary of TESAE according to MedDRA preferred Term', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Apparent Systemic Clearance (CL/F) of Maltol Glucuronide on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h', 'description': 'Descriptive statistics and population PK analysis of plasma maltol glucuronide CL/F from PK samples collected on Day 1.', 'reportingStatus': 'POSTED', 'populationDescription': 'The dose of maltol glucuronide was not calculable using non-compartmental analysis.'}, {'type': 'PRIMARY', 'title': 'Apparent Systemic Clearance (CL/F) of Maltol Glucuronide on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'OG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h', 'description': 'Descriptive statistics and population PK analysis of plasma maltol glucuronide CL/F from PK samples collected on Day 10.', 'reportingStatus': 'POSTED', 'populationDescription': 'The dose of maltol glucuronide was not calculable using non-compartmental analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'FG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'FG002', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'BG001', 'title': '16.6 mg Ferric Maltol', 'description': '13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'BG002', 'title': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.\n\nFerric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '1.56', 'groupId': 'BG000'}, {'value': '13.7', 'spread': '1.80', 'groupId': 'BG001'}, {'value': '14.2', 'spread': '2.12', 'groupId': 'BG002'}, {'value': '14.0', 'spread': '1.80', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '10-14', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': '15-17', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.590', 'spread': '0.0641', 'groupId': 'BG000'}, {'value': '1.601', 'spread': '0.855', 'groupId': 'BG001'}, {'value': '1.618', 'spread': '0.0914', 'groupId': 'BG002'}, {'value': '1.603', 'spread': '0.0799', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '57.83', 'spread': '20.961', 'groupId': 'BG000'}, {'value': '62.77', 'spread': '23.330', 'groupId': 'BG001'}, {'value': '52.07', 'spread': '9.661', 'groupId': 'BG002'}, {'value': '57.41', 'spread': '18.758', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.695', 'spread': '7.4067', 'groupId': 'BG000'}, {'value': '24.265', 'spread': '7.7647', 'groupId': 'BG001'}, {'value': '19.760', 'spread': '2.7049', 'groupId': 'BG002'}, {'value': '22.182', 'spread': '6.4355', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Haemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '12.27', 'spread': '0.856', 'groupId': 'BG000'}, {'value': '12.75', 'spread': '1.067', 'groupId': 'BG001'}, {'value': '12.37', 'spread': '1.418', 'groupId': 'BG002'}, {'value': '12.47', 'spread': '1.124', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ferritin', 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '7.18', 'groupId': 'BG000'}, {'value': '18.8', 'spread': '8.29', 'groupId': 'BG001'}, {'value': '13.8', 'spread': '8.34', 'groupId': 'BG002'}, {'value': '16.3', 'spread': '8.02', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μg/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-08', 'size': 1766257, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-25T07:05', 'hasProtocol': True}, {'date': '2018-05-11', 'size': 597473, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-25T07:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized in a 1:1:1 ratio and stratified by co-variates for age and sex. This will ensure that a minimum of 25% of each gender and at least 3 children per age group are enrolled in each Ferric Maltol dose group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2017-05-23', 'resultsFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-18', 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration [Cmax] of Maltol Glucuronide on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Maximum Plasma Concentration [Cmax] of Maltol Glucuronide on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Area Under The Curve [AUC] of Maltol Glucuronide on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide AUC from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Area Under The Curve [AUC] of Maltol Glucuronide on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol AUC from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Average Plasma Concentration [Cave(0-6h)] of Maltol Glucuronide on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Cave(0-6h) from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Time of Maximum Plasma Concentration [Tmax] of Maltol Glucuronide on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Time of Maximum Plasma Concentration [Tmax] of Maltol Glucuronide on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Half Life [t1/2] of Maltol Glucuronide on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of maltol glucuronide t1/2 from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Ratio of Maximum Plasma Concentration [Cmax] of Maltol Glucuronide on Day 10/Day 1', 'timeFrame': 'Day 1 and Day 10, pre-dose and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics of ratio maltol glucuronide Cmax Day 10/Day 10 from PK samples collected on Day 1 and Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Ratio of Area Under The Curve [AUC] of Maltol Glucuronide on Day 10/Day 1', 'timeFrame': 'Day 1 and Day 10, pre-dose and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics of ratio maltol glucuronide AUC Day 10/Day 10 from PK samples collected on Day 1 and Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Average Serum Concentration [Cave(0-6h)] of Iron on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of iron Cave(0-6h) from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Change From Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in Serum Iron on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of change in serum iron \\[Ctrough to Cmax\\] from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Change From Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in Serum Iron on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of change in serum iron \\[Ctrough to Cmax\\] from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Serum Iron on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Serum Iron on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Transferrin Saturation (TSAT) on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Transferrin Saturation (TSAT) on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Apparent Systemic Clearance (CL/F) of Iron on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 1'}, {'measure': 'Apparent Systemic Clearance (CL/F) of Iron on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 10'}, {'measure': 'Apparent Volume of Distribution (V/F) of Iron on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of iron V/F from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Apparent Volume of Distribution (V/F) of Transferrin Saturation (TSAT) on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of TSAT V/F from PK samples collected on Day 1'}, {'measure': 'Apparent Volume of Distribution (V/F) of Transferrin Saturation (TSAT) on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of TSAT V/F from PK samples collected on Day 10'}, {'measure': 'Ratio Auc(0-6) Maltol Glucuronide Day 10/Day 1', 'timeFrame': 'Day 1 to Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Ratio AUC0-6h measured after last dose of Ferric Maltol on Day 10 vs first dose Day 1.'}, {'measure': 'Serum Iron - RAUC(0-6h) D10/D1', 'timeFrame': 'Measured after first and last dose of Ferric Maltol on Day 1 & Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Serum Iron - RAUC(0-6h) Day 10/Day 1'}, {'measure': 'Transferrin Saturation (%) Day 1, Baseline', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 1 (0h)', 'description': 'Transferrin Saturation (TSAT%) Day 1, baseline'}, {'measure': 'Transferrin Saturation (%) Day 1, Maximum Response (%)', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 1 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Transferrin Saturation (TSAT%) Day 1, maximum response (%)'}, {'measure': 'Transferrin Saturation Day 1, Time to Maximum Response Tmax', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 1. (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Transferrin Saturation (TSAT%) Day 1, time to maximum response Tmax (h). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Transferrin Saturation (%) Day 10, Maximum Response (%)', 'timeFrame': 'Measured after last dose of Ferric Maltol on Day 10. (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Transferrin Saturation (TSAT%) Day 10, maximum response (%). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Transferrin Saturation Day 10, Time to Maximum Response Tmax', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 10. (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h).', 'description': 'Transferrin Saturation (TSAT%) Day 1, time to maximum response Tmax (h). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'AUC0-inf Day 1 for Maltol Glucuronide', 'timeFrame': 'Measured after first dose of Ferric Maltol on Day 1 (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'AUC0-inf for Maltol Glucuronide from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'AUC0-tau Day 10 for Maltol Glucuronide', 'timeFrame': 'Measured after last dose of Ferric Maltol on Day 10. (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'AUC0-tau for Maltol Glucuronide from PK samples collected on Day 10. Area under the plasma concentration versus time curve from time 0 to tau.'}, {'measure': 'Cthrough for Maltol Glucuronide Day 10', 'timeFrame': 'Day 10 pre-dose to last (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Change from pre-dose to last PK samples collected on Day 10 for maltol glucuronide.Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Serum Iron Cmax Day 1', 'timeFrame': 'Day 1 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Maximum serum concentration of serum iron on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.'}, {'measure': 'Serum Iron Cmax on Day 10', 'timeFrame': 'Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Maximum serum concentration of serum iron on Day 10.'}, {'measure': 'Plasma Maltol Glucuronide Cthrough D10/Day1', 'timeFrame': 'Day 10 (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Minimum concentration between dose time and dose time+TAU'}, {'measure': 'Apparent Systemic Clearance (CL/F) of Transferrin Saturation (TSAT) on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h', 'description': 'Descriptive statistics and population PK analysis of serum TSAT CL/F from PK samples collected on Day 1'}, {'measure': 'Apparent Systemic Clearance (CL/F) of Transferrin Saturation (TSAT) on Day 10', 'timeFrame': 'Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)', 'description': 'Descriptive statistics and population PK analysis of serum TSAT CL/F from PK samples collected on Day 10'}, {'measure': 'Apparent Systemic Clearance (CL/F) of Maltol Glucuronide on Day 1', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h', 'description': 'Descriptive statistics and population PK analysis of plasma maltol glucuronide CL/F from PK samples collected on Day 1.'}, {'measure': 'Apparent Systemic Clearance (CL/F) of Maltol Glucuronide on Day 10', 'timeFrame': 'Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h', 'description': 'Descriptive statistics and population PK analysis of plasma maltol glucuronide CL/F from PK samples collected on Day 10.'}], 'secondaryOutcomes': [{'measure': 'Transferrin - Change From Baseline to Day 10, Predose', 'timeFrame': 'Day 1 pre-dose to Day 10 pre-dose (0h on each day)', 'description': 'Change calculated as difference in values measured at Day 1, predose (Baseline) and on Day 10, predose'}, {'measure': 'Ferritin - Change From Baseline to Day 10, Predose', 'timeFrame': 'Pre-dose on Day 1 to Day 10 (0h)', 'description': 'Change calculated as difference in values measured at Day 1, predose (Baseline) and on Day 10, predose.'}, {'measure': 'Total Iron Binding Capacity - Change From Day 1 to Day 10, Predose', 'timeFrame': 'Predose from Day 1 to Day 10 (0h on each day)', 'description': 'Change calculated as difference in values measured at Day 1, predose and on Day 10, predose'}, {'measure': 'UIBC - Change From Day 1 to Day 10, Predose', 'timeFrame': 'Pre-dose on Day 1 to Day 10 (0h each day)', 'description': 'Change calculated as difference in values measured at Day 1, predose and on Day 10, predose'}, {'measure': 'Negative and Positive NTBI Tests on Day 1', 'timeFrame': 'Day 1 (0h)', 'description': 'Negative and Positive Non-Transferrin Bound Iron \\[NTBI\\] tests on Day 1, predose'}, {'measure': 'Change From Baseline to Day 10 in Haemoglobin Concentration', 'timeFrame': 'Screening and Day 10 (1-4 hours post-dose)', 'description': 'Change calculated as difference in values measured at Screening (Baseline) and on Day 10'}, {'measure': 'Change From Baseline to Day 10 in Absolute Reticulocyte Count', 'timeFrame': 'Change calculated as difference in values measured at Screening (Baseline) and on Day 10.', 'description': 'Change from Baseline to Day 10 in Absolute Reticulocyte Count collected from PK samples'}, {'measure': 'Treatment-emergent Adverse Events (AEs) Leading to Premature Discontinuation of Study Drug/PK Assessments', 'timeFrame': 'From first dose of Ferric Maltol on Day 1 through study completion, on average 4 weeks', 'description': 'Descriptive summary of incidence and causal relationship of treatment-emergent adverse events leading to discontinuation of study drug/PK assessments according to MedDRA preferred term (PT) and system organ class (SOC)'}, {'measure': 'Changes in 12-lead ECG Parameters From Screening to Day 10', 'timeFrame': 'Screening and Day 10 (1-4 hours post-dose)', 'description': 'Overall clinical interpretation of routine ECG parameters from Screening to Day 10'}, {'measure': 'Concomitant Medications', 'timeFrame': 'Screening, Day 1, Day 10 and Post-Study Follow-up visit, on average 4 weeks', 'description': 'Number of subjects with concomitant medications Taken by \\>5% of Subjects'}, {'measure': 'Negative and Positive NTBI Tests on Day 10, Predose', 'timeFrame': 'Day 10', 'description': 'Negative and Positive Non-Transferrin Bound Iron \\[NTBI\\] tests on Day 10, predose'}, {'measure': 'Treatment-emergent Serious Adverse Event (TESAE)', 'timeFrame': 'From first dose of ferric maltol Day 1 through study completions, on average 4 weeks', 'description': 'Descriptive summary of TESAE according to MedDRA preferred Term'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency, Anaemia in Children', 'Iron-Deficiency']}, 'descriptionModule': {'briefSummary': 'The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in comparison to the EU-approved 30mg BID dose in adults with IDA in IBD.', 'detailedDescription': 'Phase I, open label, randomized, repeat dose, multicentre, pharmacokinetic study to assess the Safety and Tolerability of Ferric Maltol in 3 different dosages.\n\n36 eligible patients will be randomized in a 1:1:1 ratio to one of the following 3 dosages for 9 days BID and a single dose on Day 10:\n\n* 30mg ferric maltol capsules\n* 16.6 mg ferric maltol capsules\n* 7.8 mg ferric maltol capsules\n\nSubject participation in the study will consist of 3 stages:\n\nScreening: up to 14 days Treatment period: 10 days treatment period with 2 visits on Day 1 and Day 10 for PK blood sampling. Patients will be randomly allocated to one of the three Ferric Maltol dose groups according to centralized treatment allocation scheme.\n\nPost-treatment Safety Follow-up:3-10 days following completion of the treatment period or premature discontinuation of study medication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to understand the information given in the Independent Ethics Committee (IEC) approved Information Sheet and Consent form. The parent or guardian of the study subject must sign and date the informed consent and authorisation to use protected health information (PHI) in accordance with national and local subject privacy regulations prior to any study mandated procedure. The study participant will be asked to provide their assent to participate in the study using the IEC approved Assent form.\n2. Willing and able to comply with study requirements.\n3. Age ≥10 to ≤17 years at the time of informed consent and throughout duration of the study.\n4. A current diagnosis of iron deficiency (with or without anaemia); iron deficiency defined by ferritin \\<30 µg/L, or ferritin \\<50 µg/L with transferrin saturation (TSAT) \\<20%, as measured by the central laboratory at the Screening visit (subjects with or without anaemia may be enrolled providing Hb is ≥8.5 g/dL as measured at the Screening visit).\n5. Where appropriate, female subjects of childbearing potential must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, a vasectomized partner and oral contraceptive medications.\n\nExclusion Criteria:\n\n1. Has untreated or untreatable severe malabsorption syndrome e.g., untreated coeliac disease\n2. Has received within 28 days prior to Screening intramuscular or intravenous (IV) injection or administration of depot iron preparation.\n3. Has received oral iron supplementation within 7 days prior to Screening\n4. Has received blood transfusion within 12 weeks prior to Screening or is scheduled to have blood transfusion or donations during the study period.\n5. Has concomitant disease that would significantly compromise iron absorption or absorbed iron utilisation such as swallowing disorders and/or extensive small bowel resection.\n6. Has chronic renal disease (eGFR \\<30mL/min), as assessed at Screening based on serum creatinine.\n7. Known hypersensitivity or allergy to either the active substance or excipients of Ferric Maltol capsules.\n8. Has a known contraindication for treatment with iron preparations, e.g. haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassemia, or lead intoxication induced anaemia.\n9. Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate transaminase (AST)\\>2.0 times upper normal limit as measured at the Screening visit.\n10. Active acute inflammatory disease, including IBD flare or disease exacerbation, which in the opinion of the Investigator, is clinically significant.\n11. Active chronic or acute infectious diseases requiring antibiotic treatment.\n12. Pregnant or breast feeding.\n13. Concomitant medical conditions with extensive active bleeding, other than menstrual cycles; subjects who suffer from menorrhagia may be included at the Investigator's discretion.\n14. Scheduled or expected hospitalisation and/or surgery during the course of the study\n15. Participation in any other interventional clinical study within 28 days prior to Screening.\n16. Cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal, immunologic, endocrine, metabolic, respiratory or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or objectives of the study drug or severely limit the lifespan of the subject.\n17. Any other unspecified reason that, in the opinion of the Investigator or the Sponsor make the subject unsuitable for enrolment."}, 'identificationModule': {'nctId': 'NCT03181451', 'briefTitle': 'Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shield Therapeutics'}, 'officialTitle': 'A Phase 1, Open-Label, Randomised, Repeat Dose, Parallel Group Study to Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects Aged 10-17 Years of Age With Iron Deficiency', 'orgStudyIdInfo': {'id': 'ST10-01-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '30 mg Ferric Maltol', 'description': '12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.', 'interventionNames': ['Drug: Ferric Maltol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '16.6 mg Ferric Maltol', 'description': '12 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.', 'interventionNames': ['Drug: Ferric Maltol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7.8 mg Ferric Maltol', 'description': '12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8mg dose on the morning of Day 10. PK study Day 1 \\& Day 10.', 'interventionNames': ['Drug: Ferric Maltol']}], 'interventions': [{'name': 'Ferric Maltol', 'type': 'DRUG', 'otherNames': ['ST10', 'Feraccru'], 'description': 'To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.', 'armGroupLabels': ['16.6 mg Ferric Maltol', '30 mg Ferric Maltol', '7.8 mg Ferric Maltol']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'L14 5AB', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': "Alder Hey Children's NHS Foundation Trust", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': "Royal Manchester Children's Hospital", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shield Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medpace, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}