Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-25 @ 6:31 PM
Study NCT ID:
NCT02654002
Status:
COMPLETED
Last Update Posted:
2020-10-12
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000717094', 'term': 'cilofexor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose date up to last dose date (Maximum: 20 days) plus 30 days', 'description': 'The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'All Placebo', 'description': 'Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}], 'classes': [{'categories': [{'measurements': [{'value': '1236.0', 'spread': '384.65', 'groupId': 'OG000'}, {'value': '2450.6', 'spread': '921.70', 'groupId': 'OG001'}, {'value': '7712.1', 'spread': '7270.76', 'groupId': 'OG002'}, {'value': '12458.8', 'spread': '4223.12', 'groupId': 'OG003'}, {'value': '4979.5', 'spread': '2039.07', 'groupId': 'OG004'}, {'value': '3091.4', 'spread': '752.66', 'groupId': 'OG005'}, {'value': '1301.9', 'spread': '388.51', 'groupId': 'OG006'}, {'value': '905.9', 'spread': '210.24', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.', 'unitOfMeasure': 'hours*nanogram/millilitre (h*ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set included all randomized participants who took at least 1 dose of Cilofexor and had at least 1 non-missing post-dose concentration value reported by the PK laboratory for each corresponding analyte.'}, {'type': 'PRIMARY', 'title': 'Single-Dose PK Parameter: AUCinf of Cilofexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}], 'classes': [{'categories': [{'measurements': [{'value': '1255.9', 'spread': '382.37', 'groupId': 'OG000'}, {'value': '2473.4', 'spread': '920.85', 'groupId': 'OG001'}, {'value': '7743.7', 'spread': '7273.50', 'groupId': 'OG002'}, {'value': '12495.7', 'spread': '4230.00', 'groupId': 'OG003'}, {'value': '5016.7', 'spread': '2022.94', 'groupId': 'OG004'}, {'value': '3559.2', 'spread': '1092.73', 'groupId': 'OG005'}, {'value': '1409.3', 'spread': '428.33', 'groupId': 'OG006'}, {'value': '924.0', 'spread': '216.60', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'Single-Dose PK Parameter: Cmax of Cilofexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}], 'classes': [{'categories': [{'measurements': [{'value': '304.2', 'spread': '126.66', 'groupId': 'OG000'}, {'value': '580.2', 'spread': '283.79', 'groupId': 'OG001'}, {'value': '2592.3', 'spread': '3059.31', 'groupId': 'OG002'}, {'value': '3055.5', 'spread': '2022.27', 'groupId': 'OG003'}, {'value': '927.6', 'spread': '540.94', 'groupId': 'OG004'}, {'value': '665.9', 'spread': '152.30', 'groupId': 'OG005'}, {'value': '340.2', 'spread': '124.44', 'groupId': 'OG006'}, {'value': '209.8', 'spread': '63.24', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Cmax is defined as the maximum observed concentration of drug in plasma.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'Multiple-Dose PK Parameter: AUCtau of Cilofexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}], 'classes': [{'categories': [{'measurements': [{'value': '1284.9', 'spread': '460.35', 'groupId': 'OG000'}, {'value': '2891.0', 'spread': '680.10', 'groupId': 'OG001'}, {'value': '6719.4', 'spread': '3980.90', 'groupId': 'OG002'}, {'value': '8486.0', 'spread': '4139.86', 'groupId': 'OG003'}, {'value': '4182.7', 'spread': '1956.03', 'groupId': 'OG004'}, {'value': '3698.3', 'spread': '837.91', 'groupId': 'OG005'}, {'value': '1293.5', 'spread': '250.95', 'groupId': 'OG006'}, {'value': '848.2', 'spread': '213.82', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUCtau is the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'Multiple-Dose PK Parameter: Cmax of Cilofexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}], 'classes': [{'categories': [{'measurements': [{'value': '322.2', 'spread': '136.70', 'groupId': 'OG000'}, {'value': '717.5', 'spread': '235.50', 'groupId': 'OG001'}, {'value': '2231.2', 'spread': '1693.78', 'groupId': 'OG002'}, {'value': '2327.9', 'spread': '1897.48', 'groupId': 'OG003'}, {'value': '818.7', 'spread': '437.28', 'groupId': 'OG004'}, {'value': '697.8', 'spread': '145.60', 'groupId': 'OG005'}, {'value': '290.4', 'spread': '78.71', 'groupId': 'OG006'}, {'value': '187.0', 'spread': '57.10', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Cmax is defined as the maximum observed concentration of drug in plasma.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set with available data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Multiple-Dose PK Parameter: Ctau of Cilofexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '3.97', 'groupId': 'OG001'}, {'value': '36.3', 'spread': '15.44', 'groupId': 'OG002'}, {'value': '70.1', 'spread': '39.46', 'groupId': 'OG003'}, {'value': '22.6', 'spread': '8.44', 'groupId': 'OG004'}, {'value': '107.6', 'spread': '84.58', 'groupId': 'OG005'}, {'value': '28.4', 'spread': '14.13', 'groupId': 'OG006'}, {'value': '3.0', 'spread': '1.54', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Ctau is defined as the observed drug concentration at the end of the dosing interval.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Analysis Set with available data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG008', 'title': 'All Placebo', 'description': 'Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '41.7', 'groupId': 'OG004'}, {'value': '27.3', 'groupId': 'OG005'}, {'value': '75.0', 'groupId': 'OG006'}, {'value': '18.2', 'groupId': 'OG007'}, {'value': '29.2', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose date (Maximum: 20 days) plus 30 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG008', 'title': 'All Placebo', 'description': 'Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then receive placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose date (Maximum: 20 days) plus 30 days', 'description': 'Investigator determined the ECG findings were clinically significant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed. Participants were grouped according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG008', 'title': 'All Placebo', 'description': 'Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.'}], 'classes': [{'title': 'Activated Partial Thromboplastin Time: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}]}]}, {'title': 'Hemoglobin-Hypo: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '8.3', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '18.2', 'groupId': 'OG005'}, {'value': '25.0', 'groupId': 'OG006'}, {'value': '27.3', 'groupId': 'OG007'}, {'value': '29.2', 'groupId': 'OG008'}]}]}, {'title': 'Hemoglobin-Hypo: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '8.3', 'groupId': 'OG003'}, {'value': '8.3', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '16.7', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '8.3', 'groupId': 'OG008'}]}]}, {'title': 'Hemoglobin-Hypo: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 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'8.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '18.2', 'groupId': 'OG005'}, {'value': '50.0', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '4.2', 'groupId': 'OG008'}]}]}, {'title': 'Total Bilirubin-Hyper:Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '8.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '4.2', 'groupId': 'OG008'}]}]}, {'title': 'Total Cholesterol-Hyper:Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '36.4', 'groupId': 'OG005'}, {'value': '25.0', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '12.5', 'groupId': 'OG008'}]}]}, {'title': 'Total Cholesterol-Hyper:Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '8.3', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '4.2', 'groupId': 'OG008'}]}]}, {'title': 'Uric Acid-Hyper:Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}]}]}, {'title': 'Uric Acid-Hypo:Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '8.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}]}]}, {'title': 'Occult Blood: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '8.3', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '8.3', 'groupId': 'OG008'}]}]}, {'title': 'Occult Blood: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '8.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '12.5', 'groupId': 'OG008'}]}]}, {'title': 'Occult Blood: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}, {'value': '8.3', 'groupId': 'OG004'}, {'value': '18.2', 'groupId': 'OG005'}, {'value': '16.7', 'groupId': 'OG006'}, {'value': '18.2', 'groupId': 'OG007'}, {'value': '8.3', 'groupId': 'OG008'}]}]}, {'title': 'Urine Glucose: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}]}]}, {'title': 'Urine Protein: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '4.2', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose date (Maximum: 20 days) plus 30 days', 'description': 'Treatment-emergent laboratory (Hematology, Chemistry, and Urinalysis) abnormalities were defined as values that increase at least one toxicity grade from baseline. Laboratory Abnormalities are graded by the investigator as Grade 1, 2, 3, or 4 according to the modified Gilead Sciences, Inc (GSI) Grading Scale. The most severe graded abnormality from all tests was counted for each participant. Data is only reported for those Grades reported in 1 or more participants.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed. Participants were grouped according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'All Fasted Placebo', 'description': 'Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG008', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG009', 'title': 'All Fed Placebo', 'description': 'Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.'}], 'classes': [{'title': 'Day 1/Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2.040', 'groupId': 'OG000', 'lowerLimit': '1.571', 'upperLimit': '2.650'}, {'value': '1.958', 'groupId': 'OG001', 'lowerLimit': '1.478', 'upperLimit': '2.594'}, {'value': '2.037', 'groupId': 'OG002', 'lowerLimit': '1.699', 'upperLimit': '2.442'}, {'value': '2.314', 'groupId': 'OG003', 'lowerLimit': '1.958', 'upperLimit': '2.735'}, {'value': '0.981', 'groupId': 'OG004', 'lowerLimit': '0.777', 'upperLimit': '1.240'}, {'value': '2.406', 'groupId': 'OG005', 'lowerLimit': '2.196', 'upperLimit': '2.637'}, {'value': '2.629', 'groupId': 'OG006', 'lowerLimit': '2.369', 'upperLimit': '2.917'}, {'value': '1.743', 'groupId': 'OG007', 'lowerLimit': '1.463', 'upperLimit': '2.076'}, {'value': '1.372', 'groupId': 'OG008', 'lowerLimit': '1.132', 'upperLimit': '1.663'}, {'value': '0.916', 'groupId': 'OG009', 'lowerLimit': '0.799', 'upperLimit': '1.050'}]}]}, {'title': 'Day 20/Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2.270', 'groupId': 'OG000', 'lowerLimit': '1.500', 'upperLimit': '3.435'}, {'value': '2.261', 'groupId': 'OG001', 'lowerLimit': '1.782', 'upperLimit': '2.868'}, {'value': '2.054', 'groupId': 'OG002', 'lowerLimit': '1.727', 'upperLimit': '2.442'}, {'value': '2.179', 'groupId': 'OG003', 'lowerLimit': '1.632', 'upperLimit': '2.911'}, {'value': '1.249', 'groupId': 'OG004', 'lowerLimit': '0.929', 'upperLimit': '1.681'}, {'value': '1.795', 'groupId': 'OG005', 'lowerLimit': '1.544', 'upperLimit': '2.086'}, {'value': '2.119', 'groupId': 'OG006', 'lowerLimit': '1.728', 'upperLimit': '2.598'}, {'value': '1.650', 'groupId': 'OG007', 'lowerLimit': '1.301', 'upperLimit': '2.093'}, {'value': '1.509', 'groupId': 'OG008', 'lowerLimit': '1.325', 'upperLimit': '1.719'}, {'value': '0.963', 'groupId': 'OG009', 'lowerLimit': '0.762', 'upperLimit': '1.216'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD Analysis Set included all randomized participants who received at least 1 dose of study drug and had the necessary baseline and on-study measurement to provide interpretable results for each respective PD parameter. Included participants with available data.'}, {'type': 'SECONDARY', 'title': 'PD Parameter: FGF19 Cmax Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'All Fasted Placebo', 'description': 'Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG008', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG009', 'title': 'All Fed Placebo', 'description': 'Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.'}], 'classes': [{'title': 'Day 1/Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2.217', 'groupId': 'OG000', 'lowerLimit': '1.667', 'upperLimit': '2.949'}, {'value': '2.084', 'groupId': 'OG001', 'lowerLimit': '1.468', 'upperLimit': '2.957'}, {'value': '2.259', 'groupId': 'OG002', 'lowerLimit': '1.742', 'upperLimit': '2.930'}, {'value': '2.679', 'groupId': 'OG003', 'lowerLimit': '2.113', 'upperLimit': '3.398'}, {'value': '0.982', 'groupId': 'OG004', 'lowerLimit': '0.759', 'upperLimit': '1.272'}, {'value': '2.793', 'groupId': 'OG005', 'lowerLimit': '2.264', 'upperLimit': '3.446'}, {'value': '2.973', 'groupId': 'OG006', 'lowerLimit': '2.578', 'upperLimit': '3.428'}, {'value': '1.961', 'groupId': 'OG007', 'lowerLimit': '1.588', 'upperLimit': '2.422'}, {'value': '1.689', 'groupId': 'OG008', 'lowerLimit': '1.354', 'upperLimit': '2.106'}, {'value': '0.929', 'groupId': 'OG009', 'lowerLimit': '0.810', 'upperLimit': '1.065'}]}]}, {'title': 'Day 20/Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2.157', 'groupId': 'OG000', 'lowerLimit': '1.345', 'upperLimit': '3.460'}, {'value': '2.393', 'groupId': 'OG001', 'lowerLimit': '1.770', 'upperLimit': '3.235'}, {'value': '2.325', 'groupId': 'OG002', 'lowerLimit': '1.804', 'upperLimit': '2.996'}, {'value': '3.084', 'groupId': 'OG003', 'lowerLimit': '2.194', 'upperLimit': '4.334'}, {'value': '1.210', 'groupId': 'OG004', 'lowerLimit': '0.910', 'upperLimit': '1.608'}, {'value': '2.241', 'groupId': 'OG005', 'lowerLimit': '1.850', 'upperLimit': '2.713'}, {'value': '2.455', 'groupId': 'OG006', 'lowerLimit': '1.964', 'upperLimit': '3.069'}, {'value': '1.768', 'groupId': 'OG007', 'lowerLimit': '1.270', 'upperLimit': '2.462'}, {'value': '1.878', 'groupId': 'OG008', 'lowerLimit': '1.527', 'upperLimit': '2.310'}, {'value': '0.874', 'groupId': 'OG009', 'lowerLimit': '0.680', 'upperLimit': '1.123'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Cmax is defined as the maximum observed concentration of FGF19 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmax Day 1 /Cmax Day-1. The ratio reported for Day 20 is the Cmax Day 20 /Cmax Day-1.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PD Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'All Fasted Placebo', 'description': 'Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG008', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG009', 'title': 'All Fed Placebo', 'description': 'Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.'}], 'classes': [{'title': 'Day 1/Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.681', 'groupId': 'OG000', 'lowerLimit': '0.431', 'upperLimit': '1.077'}, {'value': '0.640', 'groupId': 'OG001', 'lowerLimit': '0.516', 'upperLimit': '0.794'}, {'value': '0.427', 'groupId': 'OG002', 'lowerLimit': '0.340', 'upperLimit': '0.537'}, {'value': '0.347', 'groupId': 'OG003', 'lowerLimit': '0.278', 'upperLimit': '0.433'}, {'value': '1.147', 'groupId': 'OG004', 'lowerLimit': '0.921', 'upperLimit': '1.429'}, {'value': '0.837', 'groupId': 'OG005', 'lowerLimit': '0.629', 'upperLimit': '1.114'}, {'value': '0.653', 'groupId': 'OG006', 'lowerLimit': '0.581', 'upperLimit': '0.735'}, {'value': '0.863', 'groupId': 'OG007', 'lowerLimit': '0.747', 'upperLimit': '0.997'}, {'value': '1.108', 'groupId': 'OG008', 'lowerLimit': '0.828', 'upperLimit': '1.483'}, {'value': '1.057', 'groupId': 'OG009', 'lowerLimit': '0.893', 'upperLimit': '1.252'}]}]}, {'title': 'Day 20/Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.661', 'groupId': 'OG000', 'lowerLimit': '0.456', 'upperLimit': '0.959'}, {'value': '0.382', 'groupId': 'OG001', 'lowerLimit': '0.277', 'upperLimit': '0.525'}, {'value': '0.495', 'groupId': 'OG002', 'lowerLimit': '0.348', 'upperLimit': '0.704'}, {'value': '0.325', 'groupId': 'OG003', 'lowerLimit': '0.223', 'upperLimit': '0.474'}, {'value': '1.213', 'groupId': 'OG004', 'lowerLimit': '0.828', 'upperLimit': '1.777'}, {'value': '0.621', 'groupId': 'OG005', 'lowerLimit': '0.414', 'upperLimit': '0.933'}, {'value': '0.173', 'groupId': 'OG006', 'lowerLimit': '0.109', 'upperLimit': '0.275'}, {'value': '0.624', 'groupId': 'OG007', 'lowerLimit': '0.472', 'upperLimit': '0.825'}, {'value': '0.974', 'groupId': 'OG008', 'lowerLimit': '0.677', 'upperLimit': '1.402'}, {'value': '0.843', 'groupId': 'OG009', 'lowerLimit': '0.681', 'upperLimit': '1.043'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PD Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'PD Parameter: C4 Cmin Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG004', 'title': 'All Fasted Placebo', 'description': 'Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.'}, {'id': 'OG005', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'OG006', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG007', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'OG008', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'OG009', 'title': 'All Fed Placebo', 'description': 'Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.'}], 'classes': [{'title': 'Day 1/Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.715', 'groupId': 'OG000', 'lowerLimit': '0.531', 'upperLimit': '0.964'}, {'value': '0.759', 'groupId': 'OG001', 'lowerLimit': '0.597', 'upperLimit': '0.964'}, {'value': '0.663', 'groupId': 'OG002', 'lowerLimit': '0.542', 'upperLimit': '0.810'}, {'value': '0.467', 'groupId': 'OG003', 'lowerLimit': '0.370', 'upperLimit': '0.589'}, {'value': '1.201', 'groupId': 'OG004', 'lowerLimit': '0.941', 'upperLimit': '1.532'}, {'value': '0.613', 'groupId': 'OG005', 'lowerLimit': '0.497', 'upperLimit': '0.756'}, {'value': '0.348', 'groupId': 'OG006', 'lowerLimit': '0.260', 'upperLimit': '0.467'}, {'value': '0.737', 'groupId': 'OG007', 'lowerLimit': '0.590', 'upperLimit': '0.921'}, {'value': '0.961', 'groupId': 'OG008', 'lowerLimit': '0.787', 'upperLimit': '1.173'}, {'value': '1.162', 'groupId': 'OG009', 'lowerLimit': '0.981', 'upperLimit': '1.377'}]}]}, {'title': 'Day 20/Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.822', 'groupId': 'OG000', 'lowerLimit': '0.580', 'upperLimit': '1.163'}, {'value': '0.456', 'groupId': 'OG001', 'lowerLimit': '0.303', 'upperLimit': '0.687'}, {'value': '0.624', 'groupId': 'OG002', 'lowerLimit': '0.458', 'upperLimit': '0.850'}, {'value': '0.432', 'groupId': 'OG003', 'lowerLimit': '0.277', 'upperLimit': '0.675'}, {'value': '1.262', 'groupId': 'OG004', 'lowerLimit': '0.901', 'upperLimit': '1.767'}, {'value': '0.440', 'groupId': 'OG005', 'lowerLimit': '0.264', 'upperLimit': '0.733'}, {'value': '0.116', 'groupId': 'OG006', 'lowerLimit': '0.071', 'upperLimit': '0.192'}, {'value': '0.508', 'groupId': 'OG007', 'lowerLimit': '0.334', 'upperLimit': '0.773'}, {'value': '0.862', 'groupId': 'OG008', 'lowerLimit': '0.666', 'upperLimit': '1.115'}, {'value': '0.983', 'groupId': 'OG009', 'lowerLimit': '0.718', 'upperLimit': '1.346'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Cmin is defined as the minimum observed concentration of C4 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmin Day 1 /Cmin Day-1. The ratio reported for Day 20 is the Cmin Day 20 /Cmin Day-1.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PD Analysis Set with available data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'FG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'FG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'FG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'FG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'FG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'FG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'FG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'FG008', 'title': 'All Placebo', 'description': 'Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '12'}, {'groupId': 'FG008', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at one study site in the United States. The first participant was screened on 20 January 2016. The last study visit occurred on 14 July 2016.', 'preAssignmentDetails': '183 participants were screened. No participants were enrolled in Cohorts 9 and 10.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}, {'value': '118', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'BG001', 'title': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'BG002', 'title': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'BG003', 'title': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'BG004', 'title': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.'}, {'id': 'BG005', 'title': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.'}, {'id': 'BG006', 'title': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.'}, {'id': 'BG007', 'title': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.'}, {'id': 'BG008', 'title': 'All Placebo', 'description': 'Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '35', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '37', 'spread': '6.1', 'groupId': 'BG002'}, {'value': '32', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '40', 'spread': '4.6', 'groupId': 'BG004'}, {'value': '33', 'spread': '7.4', 'groupId': 'BG005'}, {'value': '35', 'spread': '6.0', 'groupId': 'BG006'}, {'value': '35', 'spread': '7.1', 'groupId': 'BG007'}, {'value': '36', 'spread': '6.7', 'groupId': 'BG008'}, {'value': '35', 'spread': '7.1', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}, {'value': '116', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '22', 'groupId': 'BG008'}, {'value': '102', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}, {'value': '118', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2016-01-11', 'resultsFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-16', 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor', 'timeFrame': 'Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.'}, {'measure': 'Single-Dose PK Parameter: AUCinf of Cilofexor', 'timeFrame': 'Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).'}, {'measure': 'Single-Dose PK Parameter: Cmax of Cilofexor', 'timeFrame': 'Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Cmax is defined as the maximum observed concentration of drug in plasma.'}, {'measure': 'Multiple-Dose PK Parameter: AUCtau of Cilofexor', 'timeFrame': 'Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUCtau is the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).'}, {'measure': 'Multiple-Dose PK Parameter: Cmax of Cilofexor', 'timeFrame': 'Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Cmax is defined as the maximum observed concentration of drug in plasma.'}, {'measure': 'Multiple-Dose PK Parameter: Ctau of Cilofexor', 'timeFrame': 'Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Ctau is defined as the observed drug concentration at the end of the dosing interval.'}, {'measure': 'Percentage of Participants With at Least One Adverse Event (AE)', 'timeFrame': 'First dose date up to last dose date (Maximum: 20 days) plus 30 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'First dose date up to last dose date (Maximum: 20 days) plus 30 days', 'description': 'Investigator determined the ECG findings were clinically significant.'}, {'measure': 'Percentage of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'First dose date up to last dose date (Maximum: 20 days) plus 30 days', 'description': 'Treatment-emergent laboratory (Hematology, Chemistry, and Urinalysis) abnormalities were defined as values that increase at least one toxicity grade from baseline. Laboratory Abnormalities are graded by the investigator as Grade 1, 2, 3, or 4 according to the modified Gilead Sciences, Inc (GSI) Grading Scale. The most severe graded abnormality from all tests was counted for each participant. Data is only reported for those Grades reported in 1 or more participants.'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio', 'timeFrame': 'Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.'}, {'measure': 'PD Parameter: FGF19 Cmax Ratio', 'timeFrame': 'Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Cmax is defined as the maximum observed concentration of FGF19 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmax Day 1 /Cmax Day-1. The ratio reported for Day 20 is the Cmax Day 20 /Cmax Day-1.'}, {'measure': 'PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio', 'timeFrame': 'Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.'}, {'measure': 'PD Parameter: C4 Cmin Ratio', 'timeFrame': 'Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose', 'description': 'Cmin is defined as the minimum observed concentration of C4 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmin Day 1 /Cmin Day-1. The ratio reported for Day 20 is the Cmin Day 20 /Cmin Day-1.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nonalcoholic Steatohepatitis (NASH)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Djedjos CS, Kirby BJ, Billin A, Gosink J, Song Q, Srihari R, et al. Pharmacodynamic Effects of the Oral, Non-Steroidal Farnesoid X Receptor Agonist GS-9674 in Healthy Volunteers. The 67th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2016 November 11-15; Boston MA United States.'}, {'type': 'BACKGROUND', 'citation': 'Kirby BJ, Djedjos CS, Birkeback J, Song Q, Grycz K, Weston J, et al. Evaluation of the Safety and Pharmacokinetics of the Oral, Nonsteroidal Farnesoid X Receptor Agonist GS-9674 in Healthy Volunteers. The 67th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2016 November 11-15; Boston MA United States.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants will receive either cilofexor or cilofexor placebo.\n\nPart A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative, blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose already evaluated.\n\nThis study is partially blinded (no one is blinded on Day -1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy male and non-pregnant, non-lactating female volunteers\n* Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m\\^2\n* Normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator\n* Normal renal function (estimated glomerular filtration rate calculated using the Cockcroft-Gault equation ≥ 80 mL/min)\n* No significant medical history, and in good general health as determined by the investigator at screening evaluation performed no more than 28 days prior to the scheduled first dose.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02654002', 'briefTitle': 'Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674, and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics', 'orgStudyIdInfo': {'id': 'GS-US-402-1851'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Cilofexor 10 mg', 'description': 'Participants in fasted state will receive cilofexor 10 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg or placebo once daily from Day 7 to Day 20.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Cilofexor 30 mg', 'description': 'Participants in fasted state will receive cilofexor 30 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 30 mg or placebo once daily from Day 7 to Day 20.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: Cilofexor 100 mg', 'description': 'Participants in fasted state will receive cilofexor 100 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg or placebo once daily from Day 7 to Day 20.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: Cilofexor 300 mg', 'description': 'Participants in fasted state will receive cilofexor 300 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 300 mg or placebo once daily from Day 7 to Day 20.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: Cilofexor 100 mg', 'description': 'Participants in fed state will receive cilofexor 100 mg or placebo once with food on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg or placebo tablet, orally, once daily with food from Day 7 to Day 20.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6: Cilofexor 50 mg', 'description': 'Participants in fed state will receive cilofexor 50 mg or placebo twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 50 mg or placebo twice daily from Day 7 to Day 20.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 7: Cilofexor 15 mg', 'description': 'Participants in fed state will receive cilofexor 15 mg or placebo twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 15 mg or placebo twice daily from Day 7 to Day 20.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 8: Cilofexor 10 mg', 'description': 'Participants in fed state will receive cilofexor 10 mg or placebo once with food on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg or placebo once daily from Day 7 to Day 20.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 9: Cilofexor', 'description': 'Participants will receive cilofexor up to 300 mg or placebo once daily in the evening on empty stomach.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 10: Cilofexor', 'description': 'Participants will receive cilofexor up to 300 mg or placebo once daily in the evening on empty stomach.', 'interventionNames': ['Drug: Cilofexor', 'Drug: Placebo']}], 'interventions': [{'name': 'Cilofexor', 'type': 'DRUG', 'otherNames': ['GS-9674'], 'description': 'Tablets administered orally', 'armGroupLabels': ['Cohort 10: Cilofexor', 'Cohort 1: Cilofexor 10 mg', 'Cohort 2: Cilofexor 30 mg', 'Cohort 3: Cilofexor 100 mg', 'Cohort 4: Cilofexor 300 mg', 'Cohort 5: Cilofexor 100 mg', 'Cohort 6: Cilofexor 50 mg', 'Cohort 7: Cilofexor 15 mg', 'Cohort 8: Cilofexor 10 mg', 'Cohort 9: Cilofexor']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets administered orally', 'armGroupLabels': ['Cohort 10: Cilofexor', 'Cohort 1: Cilofexor 10 mg', 'Cohort 2: Cilofexor 30 mg', 'Cohort 3: Cilofexor 100 mg', 'Cohort 4: Cilofexor 300 mg', 'Cohort 5: Cilofexor 100 mg', 'Cohort 6: Cilofexor 50 mg', 'Cohort 7: Cilofexor 15 mg', 'Cohort 8: Cilofexor 10 mg', 'Cohort 9: Cilofexor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'SeaView Research, Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}