Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT04309656
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2020-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018088', 'term': 'Tuberculosis, Multidrug-Resistant'}, {'id': 'D054908', 'term': 'Extensively Drug-Resistant Tuberculosis'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C410767', 'term': 'pretomanid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erica.egizi@tballiance.org', 'phone': '917-696-4984', 'title': 'Erica Egizi', 'organization': 'TB Alliance'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Day 33', 'eventGroups': [{'id': 'EG000', 'title': 'Panel 1: Treatment A', 'description': 'Each participant received four single-dose treatments. Panel 1 received a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 5, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Panel 1: Treatment B', 'description': 'Each participant received four single-dose treatments. Panel 1 received a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 9, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Panel 1: Treatment C', 'description': 'Each participant received four single-dose treatments. Panel 1 received a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 2, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Panel 1: Treatment D', 'description': 'Each participant received four single-dose treatments. Panel 1 received a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Panel 2:Treatment A', 'description': 'Each participant received four single-dose treatments. Panel 2 fasted before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Panel 2: Treatment B', 'description': 'Each participant received four single-dose treatments. Panel 2 fasted before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Panel 2: Treatment C', 'description': 'Each participant received four single-dose treatments. Panel 2 fasted before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Panel 2: Treatment D', 'description': 'Each participant received four single-dose treatments. Panel 2 fasted before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Postural orthostatic tachycardia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Bioavailability - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel 1: Pretomanid After Meal', 'description': 'Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}, {'id': 'OG001', 'title': 'Panel 2: Pretomanid After Fast', 'description': 'Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}], 'classes': [{'title': 'Treatment A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2170', 'spread': '484', 'groupId': 'OG000'}, {'value': '1180', 'spread': '401', 'groupId': 'OG001'}]}]}, {'title': 'Treatment B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1850', 'spread': '354', 'groupId': 'OG000'}, {'value': '1090', 'spread': '334', 'groupId': 'OG001'}]}]}, {'title': 'Treatment C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '389', 'spread': '58.8', 'groupId': 'OG000'}, {'value': '427', 'spread': '111', 'groupId': 'OG001'}]}]}, {'title': 'Treatment D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.7', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '110', 'spread': '20.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '85.85', 'ciLowerLimit': '81.21', 'ciUpperLimit': '90.75', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.'}, {'pValue': '0.3001', 'groupIds': ['OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.99', 'ciLowerLimit': '82.65', 'ciUpperLimit': '104.62', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.'}], 'paramType': 'MEAN', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Relative bioavailability will be determined separately for each panel using Cmax', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles'}, {'type': 'PRIMARY', 'title': 'Relative Bioavailability - AUC 0-t', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel 1: Pretomanid After Meal', 'description': 'Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}, {'id': 'OG001', 'title': 'Panel 2: Pretomanid After Fast', 'description': 'Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}], 'classes': [{'title': 'Treatment A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54900', 'spread': '10700', 'groupId': 'OG000'}, {'value': '32900', 'spread': '7580', 'groupId': 'OG001'}]}]}, {'title': 'Treatment B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55200', 'spread': '10800', 'groupId': 'OG000'}, {'value': '30200', 'spread': '9030', 'groupId': 'OG001'}]}]}, {'title': 'Treatment C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12300', 'spread': '2790', 'groupId': 'OG000'}, {'value': '10900', 'spread': '3150', 'groupId': 'OG001'}]}]}, {'title': 'Treatment D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2040', 'spread': '514', 'groupId': 'OG000'}, {'value': '2460', 'spread': '513', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6686', 'groupIds': ['OG000'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.60', 'ciLowerLimit': '98.23', 'ciUpperLimit': '103.03', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.'}, {'pValue': '0.0745', 'groupIds': ['OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.70', 'ciLowerLimit': '81.20', 'ciUpperLimit': '99.10', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.'}], 'paramType': 'MEAN', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Relative bioavailability will be determined separately for each panel using AUC 0-t (area under the time vs concentration curve from time 0 to time t : h\\*ng/mL)', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles'}, {'type': 'PRIMARY', 'title': 'Relative Bioavailability - AUC 0-inf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel 1: Pretomanid After Meal', 'description': 'Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}, {'id': 'OG001', 'title': 'Panel 2: Pretomanid After Fast', 'description': 'Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}], 'classes': [{'title': 'Treatment A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57400', 'spread': '12300', 'groupId': 'OG000'}, {'value': '34700', 'spread': '8330', 'groupId': 'OG001'}]}]}, {'title': 'Treatment B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57900', 'spread': '12400', 'groupId': 'OG000'}, {'value': '31900', 'spread': '10200', 'groupId': 'OG001'}]}]}, {'title': 'Treatment C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12700', 'spread': '3210', 'groupId': 'OG000'}, {'value': '11400', 'spread': '3440', 'groupId': 'OG001'}]}]}, {'title': 'Treatment D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2100', 'spread': '552', 'groupId': 'OG000'}, {'value': '2530', 'spread': '551', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4683', 'groupIds': ['OG000'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.03', 'ciLowerLimit': '98.65', 'ciUpperLimit': '103.47', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.'}, {'pValue': '0.0734', 'groupIds': ['OG001'], 'paramType': 'Geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.63', 'ciLowerLimit': '81.10', 'ciUpperLimit': '99.05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.'}], 'paramType': 'MEAN', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Relative bioavailability will be determined separately for each panel using AUC 0-inf (area under the time vs concentration curve from time 0 to infinite time)', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles'}, {'type': 'SECONDARY', 'title': 'Food Effect - Ratio of Cmax Fed Vs Fasted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.'}, {'id': 'OG001', 'title': 'Treatment B Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions\n\nTreatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.'}, {'id': 'OG002', 'title': 'Treatment C Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.\n\nTreatment C (test) = single 50-mg dispersible tablet, orally administered.'}, {'id': 'OG003', 'title': 'Treatment D Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.\n\nTreatment D (test) = single 10-mg dispersible tablet, orally administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '187.65', 'groupId': 'OG000', 'lowerLimit': '165.90', 'upperLimit': '212.25'}, {'value': '173.24', 'groupId': 'OG001', 'lowerLimit': '153.26', 'upperLimit': '195.82'}, {'value': '93.25', 'groupId': 'OG002', 'lowerLimit': '83.16', 'upperLimit': '104.56'}, {'value': '69.38', 'groupId': 'OG003', 'lowerLimit': '61.96', 'upperLimit': '77.68'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Food effect on bioavailability will be determined across panels using Cmax.\n\nReported in Ratio(%) of the Geometric Mean (Fed)/Geometric Mean (Fasted) based on Least Squares Mean of log-transformed parameter values (ng/mL)', 'unitOfMeasure': 'Ratio (%)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Ratio(%) = Geometric Mean (Test)/Geometric Mean (Ref). Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles'}, {'type': 'SECONDARY', 'title': 'Food Effect - Ratio of AUC 0-t Fed Vs Fasted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions\n\nTreatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.'}, {'id': 'OG001', 'title': 'Treatment B Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.'}, {'id': 'OG002', 'title': 'Treatment C Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions\n\nPretomanid: 1) Treatment C (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.'}, {'id': 'OG003', 'title': 'Treatment D Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions\n\nPretomanid: 1) Treatment D(reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '167.96', 'groupId': 'OG000', 'lowerLimit': '151.40', 'upperLimit': '186.33'}, {'value': '188.36', 'groupId': 'OG001', 'lowerLimit': '165.60', 'upperLimit': '214.26'}, {'value': '114.09', 'groupId': 'OG002', 'lowerLimit': '99.70', 'upperLimit': '130.55'}, {'value': '81.74', 'groupId': 'OG003', 'lowerLimit': '71.53', 'upperLimit': '93.42'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-t of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect.', 'unitOfMeasure': 'Ratio (%)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Ratio(%) = Geometric Mean (Test)/Geometric Mean (Ref). Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles'}, {'type': 'SECONDARY', 'title': 'Food Effect - Ratio of AUC 0-inf Fed Vs Fasted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions.\n\nTreatment A (reference) = 200 mg pretomanid given as a single 200 mg tablet (using the immediate release formulation), orally administered'}, {'id': 'OG001', 'title': 'Treatment B Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.'}, {'id': 'OG002', 'title': 'Treatment C Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions Treatment C (test) = single 50-mg dispersible tablet, orally administered.'}, {'id': 'OG003', 'title': 'Treatment D Fed and Fasted', 'description': 'Each participant will receive four single-dose treatments in both fed and fasted conditions Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '166.38', 'groupId': 'OG000', 'lowerLimit': '149.07', 'upperLimit': '185.69'}, {'value': '187.54', 'groupId': 'OG001', 'lowerLimit': '163.44', 'upperLimit': '215.20'}, {'value': '113.58', 'groupId': 'OG002', 'lowerLimit': '98.52', 'upperLimit': '130.95'}, {'value': '81.57', 'groupId': 'OG003', 'lowerLimit': '71.07', 'upperLimit': '93.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-inf of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect', 'unitOfMeasure': 'Ratio (%)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events - Overall Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel 1: Treatment A', 'description': 'Each participant received four single-dose treatments. Panel 1 received a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}, {'id': 'OG001', 'title': 'Panel 1: Treatment B', 'description': 'Each participant received four single-dose treatments. Panel 1 received a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}, {'id': 'OG002', 'title': 'Panel 1: Treatment C', 'description': 'Each participant received four single-dose treatments. Panel 1 received a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}, {'id': 'OG003', 'title': 'Panel 1: Treatment D', 'description': 'Each participant received four single-dose treatments. Panel 1 received a meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}, {'id': 'OG004', 'title': 'Panel 2:Treatment A', 'description': 'Each participant received four single-dose treatments. Panel 2 fasted before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered'}, {'id': 'OG005', 'title': 'Panel 2: Treatment B', 'description': 'Each participant received four single-dose treatments. Panel 2 fasted before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered'}, {'id': 'OG006', 'title': 'Panel 2: Treatment C', 'description': 'Each participant received four single-dose treatments. Panel 2 fasted before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered'}, {'id': 'OG007', 'title': 'Panel 2: Treatment D', 'description': 'Each participant received four single-dose treatments. Panel 2 fasted before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'throughout the study, approximately 33 days', 'description': 'All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of IMP up to and including', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panel 1: Pretomanid After Meal', 'description': 'Each participant will receive four single-dose treatments. Panel 1 will receive a required FDA standard high fat, high-calorie meal before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}, {'id': 'FG001', 'title': 'Panel 2: Pretomanid After Fast', 'description': 'Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.\n\nPretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n\n2\\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n\n3\\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All 24 participants received Treatments A, B, C and D', 'groupId': 'FG000', 'numSubjects': '24'}, {'comment': 'All 24 participants received Treatments A, B, C and D', 'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'All 24 participants received Treatments A, B, C and D', 'groupId': 'FG000', 'numSubjects': '24'}, {'comment': 'All 24 participants received Treatments A, B, C and D', 'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Panel 1: Pretomanid After Meal', 'description': 'Each participant will receive four single-dose treatments. Panel 1 will receive a required FDA standard high fat, high-calorie meal before dosing.'}, {'id': 'BG001', 'title': 'Panel 2: Pretomanid After Fast', 'description': 'Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '36.4', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '37.0', 'spread': '7.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': 'Height at Screening', 'classes': [{'categories': [{'measurements': [{'value': '170.70', 'spread': '7.962', 'groupId': 'BG000'}, {'value': '170.96', 'spread': '11.953', 'groupId': 'BG001'}, {'value': '170.83', 'spread': '10.048', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight at Screening', 'classes': [{'categories': [{'measurements': [{'value': '79.06', 'spread': '11.601', 'groupId': 'BG000'}, {'value': '78.49', 'spread': '13.633', 'groupId': 'BG001'}, {'value': '78.77', 'spread': '12.526', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI at Screening', 'classes': [{'categories': [{'measurements': [{'value': '27.08', 'spread': '2.882', 'groupId': 'BG000'}, {'value': '26.76', 'spread': '2.996', 'groupId': 'BG001'}, {'value': '26.92', 'spread': '2.913', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per meter squared', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-06', 'size': 1125383, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-26T15:32', 'hasProtocol': True}, {'date': '2020-03-09', 'size': 1020534, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-26T14:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each panel of 24 subjects will be randomized according to the same 4-sequence, 4-period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2020-01-23', 'resultsFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-22', 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Bioavailability - Cmax', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Relative bioavailability will be determined separately for each panel using Cmax'}, {'measure': 'Relative Bioavailability - AUC 0-t', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Relative bioavailability will be determined separately for each panel using AUC 0-t (area under the time vs concentration curve from time 0 to time t : h\\*ng/mL)'}, {'measure': 'Relative Bioavailability - AUC 0-inf', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Relative bioavailability will be determined separately for each panel using AUC 0-inf (area under the time vs concentration curve from time 0 to infinite time)'}], 'secondaryOutcomes': [{'measure': 'Food Effect - Ratio of Cmax Fed Vs Fasted', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Food effect on bioavailability will be determined across panels using Cmax.\n\nReported in Ratio(%) of the Geometric Mean (Fed)/Geometric Mean (Fasted) based on Least Squares Mean of log-transformed parameter values (ng/mL)'}, {'measure': 'Food Effect - Ratio of AUC 0-t Fed Vs Fasted', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-t of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect.'}, {'measure': 'Food Effect - Ratio of AUC 0-inf Fed Vs Fasted', 'timeFrame': 'intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose', 'description': 'Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-inf of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect'}, {'measure': 'Adverse Events - Overall Incidence', 'timeFrame': 'throughout the study, approximately 33 days', 'description': 'All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of IMP up to and including'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDR-TB (multi-drug resistant tuberculosis)', 'Extensively Resistant Pulmonary Tuberculosis', 'XDR-TB (extensively drug resistant tuberculosis)', 'pretomanid', 'PA-824'], 'conditions': ['Multi-drug Resistant Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '36180816', 'type': 'DERIVED', 'citation': 'Zou Y, Nedelman J, Lombardi A, Pappas F, Karlsson MO, Svensson EM. Characterizing Absorption Properties of Dispersible Pretomanid Tablets Using Population Pharmacokinetic Modelling. Clin Pharmacokinet. 2022 Nov;61(11):1585-1593. doi: 10.1007/s40262-022-01163-w. Epub 2022 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.', 'detailedDescription': 'This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects. Each panel of 24 subjects will be randomized according to the same 4-sequence, 4- period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male or female. Females must not be pregnant or breastfeeding.\n* Willing and able to comply with the contraception requirements.\n* Between 19 and 50 years of age (inclusive) at the time of screening.\n* Body mass index (BMI) between 18.50 and 32 kg/m2 (inclusive) and weighs a minimum of 50 kg.\n\nKey Exclusion Criteria:\n\n* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.\n* Vital signs at screening (measured sitting after a minimum 3 minutes rest) as follows: blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg or a heart rate lower than 40 bpm or higher than 99 bpm. Out-of-range vital signs may be repeated once.\n* History or presence of allergic or adverse response to pretomanid or related drugs.\n* Use of any drugs or treatment with any known drugs that are moderate or strong inducers or inhibitors of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) and/or P-gp, including St. John's Wort, within 30 days before the first dose of study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results.\n* Female with a positive pregnancy test result.\n* Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.\n* Hemoglobin \\<10.0 g/dL.\n* ALT (alanine transaminase) or AST (aspartate aminotransferase) \\>2.0 x the upper limit of normal (ULN).\n* Hyperbilirubinemia \\>1.5 x ULN.\n* History or presence of alcoholism or drug abuse within the past 2 years as determined by the Investigator to be clinically relevant.\n* Any clinically significant electrocardiogram abnormality at Screening (as deemed by decision of the Investigator and the Study Sponsor's Medical Monitor).\n* QTcF interval \\>450 msec for males or \\>470 msec for females at screening, Day -1, or Day 1 (pre-dose), or history of prolonged QT syndrome.\n* Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure or terminal cancer)."}, 'identificationModule': {'nctId': 'NCT04309656', 'briefTitle': 'Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid', 'organization': {'class': 'OTHER', 'fullName': 'Global Alliance for TB Drug Development'}, 'officialTitle': 'An Open-label, Randomized, Four-period, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Bioavailability, Food Effect, and Dose-dependence of Single-dose Immediate-release and Single-dose Dispersible Formulations of Pretomanid', 'orgStudyIdInfo': {'id': 'Pa-824-CL-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel 1: Pretomanid after meal', 'description': 'Each participant will receive four single-dose treatments with a 7-day washout period between each dose. Panel 1 will receive a meal before dosing.', 'interventionNames': ['Drug: Pretomanid']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2: Pretomanid after fast', 'description': 'Each participant will receive four single-dose treatments with a 7-day washout period between each dose. Panel 2 will fast before dosing.', 'interventionNames': ['Drug: Pretomanid']}], 'interventions': [{'name': 'Pretomanid', 'type': 'DRUG', 'otherNames': ['PA-824'], 'description': '1. Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.\n2. Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.\n3. Treatment C (test) = single 50-mg dispersible tablet, orally administered.\n4. Treatment D (test) = single 10-mg dispersible tablet, orally administered.', 'armGroupLabels': ['Panel 1: Pretomanid after meal', 'Panel 2: Pretomanid after fast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Worldwide Clinical Trials Early Phase Services, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Antonio Lombardi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TB Alliance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Global Alliance for TB Drug Development', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}