Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-01 @ 10:13 PM
Study NCT ID:
NCT01860703
Status:
COMPLETED
Last Update Posted:
2014-11-12
First Post:
2013-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077543', 'term': 'Deferiprone'}, {'id': 'D020084', 'term': 'Long Interspersed Nucleotide Elements'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D011728', 'term': 'Pyridones'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018626', 'term': 'Retroelements'}, {'id': 'D020071', 'term': 'Interspersed Repetitive Sequences'}, {'id': 'D012091', 'term': 'Repetitive Sequences, Nucleic Acid'}, {'id': 'D001483', 'term': 'Base Sequence'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ftricta@apopharma.com', 'phone': '416-401-7332', 'title': 'Fernando Tricta, MD', 'organization': 'ApoPharma Inc.'}, 'certainAgreement': {'otherDetails': 'All unpublished information given to the CRO by ApoPharma shall not be published or disclosed to a third party without the prior written consent of ApoPharma.\n\nThe data generated by this study are considered confidential information and the property of ApoPharma. This confidential information may be published only in collaboration with participating personnel from ApoPharma or upon ApoPharma written consent to publish the article.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of the first dose until 7 days (± 1 day) following the last study event of Period 4 or following early withdrawal.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm A - Maximum Therapeutic Dose', 'description': 'Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets, deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.\n\nDeferiprone\n\ndeferiprone matching placebo tablets\n\nmoxifloxacin matching placebo tablet', 'otherNumAtRisk': 46, 'otherNumAffected': 12, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Arm B - Supratherapeutic Dose', 'description': 'Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets, and one moxifloxacin matching placebo tablet.\n\nDeferiprone\n\nmoxifloxacin matching placebo tablet', 'otherNumAtRisk': 48, 'otherNumAffected': 35, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment Arm C - Placebo Control', 'description': 'Single dose of deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.\n\ndeferiprone matching placebo tablets\n\nmoxifloxacin matching placebo tablet', 'otherNumAtRisk': 45, 'otherNumAffected': 10, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment Arm D - Positive Control', 'description': 'Single dose of deferiprone matching placebo tablets and one 400 mg moxifloxacin tablet.\n\nDeferiprone\n\nmoxifloxacin', 'otherNumAtRisk': 46, 'otherNumAffected': 5, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Sensation of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Procedural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Electrocardiogram QRS complex prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Red blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Formication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Nasal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '33 mg/kg Deferiprone', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '4.92', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '4.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.01', 'ciLowerLimit': '1.02', 'ciUpperLimit': '5.01', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24-hour interval', 'description': "Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Maximum Therapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Treatment Arm B - Supratherapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG002', 'title': 'Arm C - Placebo Control', 'description': 'A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG003', 'title': 'Arm D - Positive Control', 'description': 'One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From administration of the first dose until 7 days +/- 1 day following the final dose', 'description': 'Number of participants with adverse events following therapeutic and supratherapeutic doses of deferiprone', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set consisted of all subjects who received at least 1 dose of study medication and had at least 1 safety assessment.'}, {'type': 'SECONDARY', 'title': 'Cmax of Deferiprone and Deferiprone 3-O Glucuronide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Maximum Therapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Treatment Arm B - Supratherapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'title': 'Cmax of serum deferiprone', 'categories': [{'measurements': [{'value': '34.1', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '54.4', 'spread': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Cmax of serum deferiprone 3-O-glucuronide', 'categories': [{'measurements': [{'value': '35.2', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '51.4', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hour interval', 'description': 'To evaluate the Cmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.\n\nSerial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.'}, {'type': 'SECONDARY', 'title': 'Tmax of Deferiprone and Deferiprone 3-O-glucuronide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Maximum Therapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Treatment Arm B - Supratherapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'title': 'Tmax of serum deferiprone', 'categories': [{'measurements': [{'value': '0.8185', 'spread': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.321', 'upperLimit': '2.13'}, {'value': '0.8175', 'spread': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.567', 'upperLimit': '4.07'}]}]}, {'title': 'Tmax of serum deferiprone -O-glucuronide', 'categories': [{'measurements': [{'value': '3.066', 'spread': '0.7', 'groupId': 'OG000', 'lowerLimit': '1.39', 'upperLimit': '4.07'}, {'value': '3.071', 'spread': '0.7', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '6.07'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24-hour interval', 'description': 'To evaluate the Tmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.\n\nSerial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.'}, {'type': 'SECONDARY', 'title': 'AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Maximum Therapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Treatment Arm B - Supratherapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'title': 'AUC0-infinity for serum deferiprone', 'categories': [{'measurements': [{'value': '95.4', 'spread': '18.03', 'groupId': 'OG000'}, {'value': '152.1', 'spread': '22.2', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-infinity for serum deferiprone -O-glucuronide', 'categories': [{'measurements': [{'value': '205.5', 'spread': '42.8', 'groupId': 'OG000'}, {'value': '331.2', 'spread': '74.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hour interval', 'description': 'AUC0-infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.\n\nSerial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.', 'unitOfMeasure': 'μg *hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.'}, {'type': 'SECONDARY', 'title': 'T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Maximum Therapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Treatment Arm B - Supratherapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'title': 'T1/2 for serum deferiprone', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'T1/2 for serum deferiprone 3-O-glucuronide', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hour interval', 'description': 'T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.\n\nSerial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.'}, {'type': 'PRIMARY', 'title': 'Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg Deferiprone', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '5.28', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '6.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.23', 'ciLowerLimit': '3.26', 'ciUpperLimit': '7.19', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24-hour interval', 'description': "Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).'}, {'type': 'PRIMARY', 'title': 'Maximum Postdose QT/QTc Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Maximum Therapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Arm B - Supratherapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG002', 'title': 'Arm C - Placebo Control', 'description': 'A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG003', 'title': 'Arm D - Positive Control', 'description': 'One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'title': 'QTcF ≤ 450 msec', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}]}, {'title': 'QTcF > 450 to ≤ 480 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'QTcF > 480 to ≤ 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTcF > 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24-hour interval', 'description': 'The maximum post-dose QT/QTc interval for deferiprone and placebo.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).'}, {'type': 'PRIMARY', 'title': 'Maximum Change From Baseline (dQT/dQTc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - Maximum Therapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Arm B - Supratherapeutic Dose', 'description': 'A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG002', 'title': 'Arm C - Placebo Control', 'description': 'A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}, {'id': 'OG003', 'title': 'Arm D - Positive Control', 'description': 'One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'title': 'QTcF ≤ 30 msec', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}]}, {'title': 'QTcF >30 but ≤ 60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'QTcF >60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24-hour interval', 'description': 'Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).'}, {'type': 'SECONDARY', 'title': 'Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Control', 'description': 'A single 400 mg tablet of moxifloxacin. The tablet was administered orally with approximately 240 mL of water.'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '6.38', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '6.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '13.42', 'ciLowerLimit': '11.10', 'ciUpperLimit': '15.75', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24-hour interval', 'description': "Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABCD', 'description': 'All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:\n\nTreatment A = single oral dose of 33 mg/kg deferiprone Treatment B = single oral dose of 50 mg/kg deferiprone Treatment C = single oral dose of placebo Treatment D = single oral dose of moxifloxacin'}, {'id': 'FG001', 'title': 'BDAC', 'description': 'All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:\n\nTreatment B = single oral dose of 50 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment A = single oral dose of 33 mg/kg deferiprone Treatment C = single oral dose of placebo'}, {'id': 'FG002', 'title': 'CADB', 'description': 'All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:\n\nTreatment C = single oral dose of placebo Treatment A = single oral dose of 33 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment B = single oral dose of 50 mg/kg deferiprone'}, {'id': 'FG003', 'title': 'DCBA', 'description': 'All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:\n\nTreatment D = single oral dose of moxifloxacin Treatment C = single oral dose of placebo Treatment B = single oral dose of 50 mg/kg deferiprone Treatment A = single oral dose of 33 mg/kg deferiprone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Personal reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First subject enrolled: 17 November 2012 Last subject completed: 19 December 2012\n\nThe study was carried out at Celerion, a research facility used for conducting clinical trials.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'Subjects in this cross-over study all received one dose of each the following: A) a maximum therapeutic dose of 33 mg deferiprone, B) a supratherapeutic dose of 50 mg/kg deferiprone, C) placebo, and D) moxifloxacin (active control). They were randomized to receive these products in different orders: ABCD, BDAC, CADB, or DCBA. Treatments were separated by a 7-day washout period.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Fifty subjects were enrolled in order to have at least 33 subjects complete the study. The sample size calculations were based on the ICH E14 Guidance which defines a negative TQT study as one "in which the upper bound of the 95% one-sided CI for the largest time-matched mean effect of the drug on the QTc interval excludes 10 msec."'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-07', 'studyFirstSubmitDate': '2013-05-06', 'resultsFirstSubmitDate': '2014-07-21', 'studyFirstSubmitQcDate': '2013-05-21', 'lastUpdatePostDateStruct': {'date': '2014-11-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-07', 'studyFirstPostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone', 'timeFrame': '24-hour interval', 'description': "Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."}, {'measure': 'Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone', 'timeFrame': '24-hour interval', 'description': "Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."}, {'measure': 'Maximum Postdose QT/QTc Interval', 'timeFrame': '24-hour interval', 'description': 'The maximum post-dose QT/QTc interval for deferiprone and placebo.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.'}, {'measure': 'Maximum Change From Baseline (dQT/dQTc)', 'timeFrame': '24-hour interval', 'description': 'Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From administration of the first dose until 7 days +/- 1 day following the final dose', 'description': 'Number of participants with adverse events following therapeutic and supratherapeutic doses of deferiprone'}, {'measure': 'Cmax of Deferiprone and Deferiprone 3-O Glucuronide', 'timeFrame': '24-hour interval', 'description': 'To evaluate the Cmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.\n\nSerial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.'}, {'measure': 'Tmax of Deferiprone and Deferiprone 3-O-glucuronide', 'timeFrame': '24-hour interval', 'description': 'To evaluate the Tmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.\n\nSerial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.'}, {'measure': 'AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide', 'timeFrame': '24-hour interval', 'description': 'AUC0-infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.\n\nSerial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.'}, {'measure': 'T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide', 'timeFrame': '24-hour interval', 'description': 'T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.\n\nSerial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose.'}, {'measure': 'Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin', 'timeFrame': '24-hour interval', 'description': "Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.\n\nECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ferriprox®', 'LI', 'DFP', 'Deferiprone', 'Healthy Volunteers'], 'conditions': ['Prolonged QTc Interval']}, 'descriptionModule': {'briefSummary': 'Randomized, single-dose, double-blind, placebo and active controlled, four-period crossover study to evaluate the effect of deferiprone on QTc prolongation after administration of a single therapeutic (33 mg/kg) and supratherapeutic(50 mg/kg) oral doses of deferiprone in healthy volunteers as compared to placebo treatment.', 'detailedDescription': 'Post-marketing study to evaluate the effect of deferiprone and deferiprone 3-O-glucuronide on QTc prolongation in healthy volunteers after administration of a single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral dose of deferiprone and moxifloxacin (Avelox®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n1. Healthy adult males or females, 18 - 45 years of age (inclusive).\n2. Body weight ≥ 50 kg.\n3. Body mass index (BMI) ≥ 19 and ≤ 32 kg/m2.\n4. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination).\n5. Absolute neutrophil count (ANC) of \\>1.5x109/L.\n6. 12-lead ECGs which have no clinically significant findings as judged by the Principal Investigator (PI) or the PI's designee at screening and check-in of each study period,including:\n\n 1. Normal sinus rhythm (heart rate between 45 and 100 bpm);\n 2. QTcF interval ≤ 450 msec;\n 3. QRS interval ≤ 110 msec; and\n 4. PR interval ≤ 220 msec.\n7. Subject must be capable of providing written informed consent, and must voluntarily consent to participate in the study.\n8. Willing to answer inclusion and exclusion criteria questionnaire at check-in.\n\nMain Exclusion Criteria:\n\n1. History or presence of significant respiratory, cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, or psychiatric disease.\n2. Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal products (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections,acute inflammations, etc.).\n3. Presence of liver impairment: aspartate aminotransferase (AST), alanine aminotransferase (ALT) above the normal reference range.\n4. Presence of significant kidney impairment: serum creatinine higher than the normal reference range.\n5. Allergy to band aids, adhesive dressing or medical tape.\n6. Clinically significant history or presence of ECG abnormalities such as second- or third-degree atrioventricular block; evidence, or family history, of prolonged QT syndrome.\n7. Sustained sitting systolic blood pressure of \\<90 mmHg or \\>140 mmHg, or diastolic blood pressure of \\>95 mmHg at screening or check-in of Period 1.\n8. History or presence of hypersensitivity or idiosyncratic reaction to deferiprone, moxifloxacin, iron chelators, or quinolone antibiotics.\n9. History or presence of:\n\n * agranulocytosis;\n * asthma;\n * chronic bronchitis;\n * diabetes;\n * migraine;\n * hypertension;\n * hypotension;\n * hypokalemia;\n * seizures or epilepsy;\n * anaemia.\n10. History or presence of alcoholism or drug abuse within the past 2 years.\n11. Used tobacco/nicotine-containing product for at least 3 months prior to the first dose of study.\n12. Used Depo-Provera® or levonorgestrel implant within 90 days prior to the first dose and throughout the study.\n13. Participation in another clinical trial within 28 days prior to the first dose of the study.\n14. Had a clinically significant illness during the 4 weeks prior to check-in on Day -1 of Period 1."}, 'identificationModule': {'nctId': 'NCT01860703', 'briefTitle': 'Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'ApoPharma'}, 'officialTitle': 'A Double-Blind, Randomized, Crossover, Thorough QT/QTc Trial to Evaluate the Potential of Deferiprone to Prolong the QT Interval in Healthy Subjects', 'orgStudyIdInfo': {'id': 'LA37-1111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A - Maximum Therapeutic Dose', 'description': 'Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets', 'interventionNames': ['Drug: Deferiprone']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm B - Supratherapeutic Dose', 'description': 'Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets', 'interventionNames': ['Drug: Deferiprone']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C - Placebo Control', 'description': 'Single dose of matching deferiprone and moxifloxacin placebo tablets.', 'interventionNames': ['Drug: deferiprone matching placebo tablets', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D - Positive Control', 'description': 'Single dose of one 400 mg moxifloxacin tablet.', 'interventionNames': ['Drug: moxifloxacin']}], 'interventions': [{'name': 'Deferiprone', 'type': 'DRUG', 'otherNames': ['Ferriprox', 'L1'], 'description': 'Ferriprox 500 mg tablets', 'armGroupLabels': ['Arm A - Maximum Therapeutic Dose', 'Treatment Arm B - Supratherapeutic Dose']}, {'name': 'deferiprone matching placebo tablets', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'deferiprone matching placebo tablets', 'armGroupLabels': ['Arm C - Placebo Control']}, {'name': 'moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avelox'], 'description': 'Active control', 'armGroupLabels': ['Arm D - Positive Control']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'moxifloxacin-matching placebo', 'armGroupLabels': ['Arm C - Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Fernando Tricta, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'ApoPharma'}, {'name': 'Caroline Fradette, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ApoPharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ApoPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}