Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT03336502
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101425', 'term': 'posaconazole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 98 days post first study dose', 'description': 'All participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'POS IV (MK-5592)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 70, 'seriousNumAtRisk': 70, 'deathsNumAffected': 6, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 64, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 25, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gingival ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 44, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 33, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 22, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 81, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 39, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Brain natriuretic peptide increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 112, 'numAffected': 38}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 81, 'numAffected': 40}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 88, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 108, 'numAffected': 50}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 28, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 35, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 32, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 75, 'numAffected': 46}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 23, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 18, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Poor quality sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Distributive shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Steady State (ss) Average Concentration (Cavg) of Posaconazole of Serial PK (Subgroup 1) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '2986.28', 'spread': '1074.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the pharmacokinetics (PK) parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With ssCavg ≥500 ng/mL of Serial PK (Subgroup 1) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'title': 'Cavg 500 ng/mL to < 2500 ng/mL', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000'}]}]}, {'title': 'Cavg 2500 ng/ML to < 3650 ng/mL', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Cavg 3650 ng/mL or higher', 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval. The percentage of participants with ssCavg ≥500 ng/mL are presented.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.'}, {'type': 'PRIMARY', 'title': 'Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of POS of Serial PK (Subgroup 1) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '71670.8', 'spread': '25788.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. AUC0-24 is defined as area under the plasma concentration-time curve from time 0 extrapolated to 24 hours.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.'}, {'type': 'PRIMARY', 'title': 'Steady State Maximum Concentration (ssCmax) of POS of Serial PK (Subgroup 1) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '4612.22', 'spread': '1221.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmax is defined as the maximum concentration of POS in plasma.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.'}, {'type': 'PRIMARY', 'title': 'Steady State Minimum Concentration (ssCmin) of POS of Serial PK (Subgroup 1) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '2311.33', 'spread': '1119.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmin is defined as the minimum concentration of POS in plasma.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.'}, {'type': 'PRIMARY', 'title': 'Time to Steady-state Maximum Concentration (ssTmax) of POS of Serial PK (Subgroup 1) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '1.63', 'spread': '0.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Tmax is defined as the time it takes to achieve maximum concentration of POS in plasma.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.'}, {'type': 'PRIMARY', 'title': 'Total Body Clearance (CL) of POS of Serial PK (Subgroup 1) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '4767.90', 'spread': '1805.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': "Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. CL is defined as the time it takes for POS to be completely removed from the body's blood stream.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.", 'unitOfMeasure': 'mL/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.'}, {'type': 'PRIMARY', 'title': 'POS Plasma Trough Concentrations in the Serial PK and Sparse PK Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1800.93', 'spread': '525.20', 'groupId': 'OG000'}, {'value': '2033', 'spread': '650.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2106.07', 'spread': '764.16', 'groupId': 'OG000'}, {'value': '2514', 'spread': '927.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2473.78', 'spread': '1247.86', 'groupId': 'OG000'}, {'value': '2466', 'spread': '1045', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2471.63', 'spread': '1495.20', 'groupId': 'OG000'}, {'value': '2680', 'spread': '1269', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2603', 'spread': '1325', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3180', 'spread': '1527', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3, Day 6, Day 10, Day 15, Day 22, Day 28', 'description': 'Pre-dose plasma trough concentrations by study day between serial PK and Sparse PK - where serial PK is defined as multiple serial blood sampling of more than 6 timepoints; and sparse PK is defined as few blood samples taken and single or limited timepoints', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable participants in Subgroup 1 (Serial PK) and Subgroup 2 (Sparse PK) not yet switched to oral suspension.\n\nBoth groups received the same dose and drug administration and reflect only different blood sampling schedules.'}, {'type': 'SECONDARY', 'title': 'Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POS IV (MK-5592)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 58 days', 'description': 'Number of participants with one or more AEs where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Discontinuations Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POS IV (MK-5592)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days', 'description': 'Number of participants discontinued from study medication due to an AE where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Medically Significant Changes in Clinical Laboratory Results - Lab Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days', 'description': 'The number of participants with clinical laboratory values outside of normal range', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable participants in Subgroup 1 (Serial PK) and Subgroup 2 (Sparse PK) not yet switched to oral suspension. Both groups received the same dose and drug administration and reflect only different blood sampling schedules.'}, {'type': 'SECONDARY', 'title': 'Medically Significant Changes in Clinical Laboratory Results - Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'OG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days', 'description': 'The number of participants with values of vital signs outside of normal range', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable participants in Subgroup 1 (Serial PK) and Subgroup 2 (Sparse PK) not yet switched to oral suspension. Both groups received the same dose and drug administration and reflect only different blood sampling schedules.'}, {'type': 'SECONDARY', 'title': 'Survival Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POS IV (MK-5592)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days.'}], 'classes': [{'title': 'Alive', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Dead', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 98 days', 'description': 'Survival assessment as to whether a participant is alive or dead, included all participants who died - 2 during study treatment, 1 during safety follow-up, 2 during survival follow-up (Day 60 to 70 post dose), and 1 participant who died during serious AE (SAE) follow-up at 97 days after first dose but was beyond the safety and the survival follow-up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Participants With Invasive Fungal Infection (IFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POS IV (MK-5592)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days', 'description': 'Number of participants with possible, probable, or proven IFI observed during the whole study period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'FG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '70', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'comment': '57', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Prohibited Drugs', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': '70 participants were randomized and 70 received at least one dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Serial PK (Subgroup 1)', 'description': 'Posaconazole (POS) 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Serial PK requires full intensive blood sampling for PK measurements'}, {'id': 'BG001', 'title': 'Sparse PK (Subgroup 2)', 'description': 'POS 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants may have received POS 300 mg IV infusion once daily or 200 mg oral suspension 3 times daily for up to 18 additional days. Sparse PK requires sparse infrequent blood sampling for PK measurements'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': '18 to 70 Years of Age', 'categories': [{'measurements': [{'value': '39.8', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '45.4', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '43', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subgroup 1 - Serial PK group, received at least 10 days of POS, and analyzed for plasma trough determination AND PK parameters Subgroup 2 - Sparse PK group, received at least 10 days of POS, and analyzed for plasma trough determination.\n\nBoth groups received the same dose and drug administration, reflect only different blood sampling schedules.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-24', 'size': 4248587, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-25T14:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-02', 'studyFirstSubmitDate': '2017-11-06', 'resultsFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-02', 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steady State (ss) Average Concentration (Cavg) of Posaconazole of Serial PK (Subgroup 1) on Day 10', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the pharmacokinetics (PK) parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.'}, {'measure': 'Percentage of Participants With ssCavg ≥500 ng/mL of Serial PK (Subgroup 1) on Day 10', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval. The percentage of participants with ssCavg ≥500 ng/mL are presented.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.'}, {'measure': 'Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of POS of Serial PK (Subgroup 1) on Day 10', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. AUC0-24 is defined as area under the plasma concentration-time curve from time 0 extrapolated to 24 hours.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.'}, {'measure': 'Steady State Maximum Concentration (ssCmax) of POS of Serial PK (Subgroup 1) on Day 10', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmax is defined as the maximum concentration of POS in plasma.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.'}, {'measure': 'Steady State Minimum Concentration (ssCmin) of POS of Serial PK (Subgroup 1) on Day 10', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmin is defined as the minimum concentration of POS in plasma.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.'}, {'measure': 'Time to Steady-state Maximum Concentration (ssTmax) of POS of Serial PK (Subgroup 1) on Day 10', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': 'Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Tmax is defined as the time it takes to achieve maximum concentration of POS in plasma.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only.'}, {'measure': 'Total Body Clearance (CL) of POS of Serial PK (Subgroup 1) on Day 10', 'timeFrame': 'Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI', 'description': "Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. CL is defined as the time it takes for POS to be completely removed from the body's blood stream.\n\nSubgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.\n\nSubgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only."}, {'measure': 'POS Plasma Trough Concentrations in the Serial PK and Sparse PK Subgroups', 'timeFrame': 'Day 3, Day 6, Day 10, Day 15, Day 22, Day 28', 'description': 'Pre-dose plasma trough concentrations by study day between serial PK and Sparse PK - where serial PK is defined as multiple serial blood sampling of more than 6 timepoints; and sparse PK is defined as few blood samples taken and single or limited timepoints'}], 'secondaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': 'Up to 58 days', 'description': 'Number of participants with one or more AEs where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Discontinuations Due to an AE', 'timeFrame': 'Up to 28 days', 'description': 'Number of participants discontinued from study medication due to an AE where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Medically Significant Changes in Clinical Laboratory Results - Lab Values', 'timeFrame': 'Up to 28 days', 'description': 'The number of participants with clinical laboratory values outside of normal range'}, {'measure': 'Medically Significant Changes in Clinical Laboratory Results - Vital Signs', 'timeFrame': 'Up to 28 days', 'description': 'The number of participants with values of vital signs outside of normal range'}, {'measure': 'Survival Status', 'timeFrame': 'Up to 98 days', 'description': 'Survival assessment as to whether a participant is alive or dead, included all participants who died - 2 during study treatment, 1 during safety follow-up, 2 during survival follow-up (Day 60 to 70 post dose), and 1 participant who died during serious AE (SAE) follow-up at 97 days after first dose but was beyond the safety and the survival follow-up period'}, {'measure': 'Participants With Invasive Fungal Infection (IFI)', 'timeFrame': 'Up to 28 days', 'description': 'Number of participants with possible, probable, or proven IFI observed during the whole study period'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fungal Infection']}, 'referencesModule': {'references': [{'pmid': '35167031', 'type': 'DERIVED', 'citation': 'Wu D, Mi Y, Weng J, Zhuang J, Ke X, Wang C, Liu K, Martinho M, Winchell GA, Zang Y, Xu L. Phase 1b/3 Pharmacokinetics and Safety Study of Intravenous Posaconazole in Adult Asian Participants at High Risk for Invasive Fungal Infections. Adv Ther. 2022 Apr;39(4):1697-1710. doi: 10.1007/s12325-021-02012-1. Epub 2022 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics and safety of posaconazole intravenous solution in Chinese participants at high risk for invasive fungal infections. Neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes will be enrolled in the study. The primary hypothesis is to evaluate the pharmacokinetic parameters of intravenous (IV) posaconazole (POS) solution in Chinese participants at high risk of invasive fungal infections and determine the percentage of Chinese participants who reach steady-state concentration averages of POS in blood plasma of 500 ng/ml and higher. Two subgroups were evaluated: Subgroup 1 from serial PK blood draw sampling and Subgroup 2 from sparse limited PK blood draw sampling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chinese participant\n* Female of reproductive potential with a serum of beta human chorionic gonadotropin (β-hCG) level consistent with a nongravid state and agree and/or have their partner use 2 acceptable methods of birth control throughout the study\n* Body Mass Index (BMI) \\>=15 and \\<=30 kg/m\\^2\n* Have a central line catheter or peripherally central venous catheter in place\n* Anticipated or documented prolonged neutropenia and likely to last for at least 7 days due to: a) standard intensive chemotherapy, anthracycline-based or other accepted regimen (excluding any investigational agent) for a new diagnosis of acute myelogenous leukemia (AML); b)chemotherapy for AML in first relapse; or c) therapy for myelodysplastic syndromes in transformation to AML or other diagnoses of secondary AML (therapy related, antecedent hematological disorders) other than chronic myelogenous leukemia in blast crisis\n* Free from any clinically significant disease other than the primary hematologic disease that would interfere with administration of study medication or study evaluations\n* Able to tolerate central IV solution\n\nExclusion Criteria:\n\n* Pregnant, intends to become pregnant during the study, or has been nursing\n* Mentally or legally incapacitated, has significant emotional problems, or has clinically significant psychiatric disorder over the last 5 years\n* Received systemic antifungal therapy (oral, intravenous, or inhaled) within 30 days of study enrollment for reasons other than antifungal prophylaxis\n* Known or suspected invasive or systemic fungal infection\n* Taken posaconazole within 10 days prior to study enrollment\n* Major surgery, donated or lost 1 unit of blood, or participated in another investigational study within 4 weeks prior to the study\n* Type 1 hypersensitivity or idiosyncratic reactions to azole agents\n* Significant multiple or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food\n* Moderate or severe liver dysfunction\n* Chronic active hepatitis, cirrhosis, Hepatocellular Carcinoma (HCC), or other hepatic disease caused by a virus\n* Previous electrocardiogram with a prolonged QTc interval\n* Prior enrollment in this study or other posaconazole studies within 90 days of study entry\n* Eastern Cooperative Oncology Group (ECOG) performance status was \\>2 prior to induction chemotherapy for the underlying disease\n* Known or suspected Gilbert's disease."}, 'identificationModule': {'nctId': 'NCT03336502', 'briefTitle': 'Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592, POS) in Chinese Subjects at High Risk for Invasive Fungal Infections', 'orgStudyIdInfo': {'id': '5592-120'}, 'secondaryIdInfos': [{'id': 'MK-5992-120', 'type': 'OTHER', 'domain': 'Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Posaconazole', 'description': 'All participants will receive posaconazole 300 mg intravenous (IV) infusion twice on Day 1 followed by 300 mg IV infusion once daily on Days 2 to 10 (±1). At the discretion of the investigator, participants will received posaconazole 300 mg IV infusion once daily or 200 mg oral suspension three times daily for up to 18 additional days.', 'interventionNames': ['Drug: Posaconazole']}], 'interventions': [{'name': 'Posaconazole', 'type': 'DRUG', 'otherNames': ['MK-5592', 'Noxafil'], 'description': 'Posaconazole 18 mg/mL IV solution; posaconazole 40 mg/mL oral suspension', 'armGroupLabels': ['Posaconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong General Hospital, Guangdong Academy of Medical Science ( Site 0002)', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Soochow University ( Site 0004)', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '100044', 'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital ( Site 0008)", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital ( Site 0009)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital ( Site 0006)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200080', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai General Hospital ( Site 0007)', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300020', 'city': 'Tianjin', 'country': 'China', 'facility': 'Institute of Hematology and Blood Diseases Hosp CAMS&PUMC ( Site 0001)', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}