Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT05458102
Status:
TERMINATED
Last Update Posted:
2024-12-03
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582524', 'term': 'vesatolimod'}, {'id': 'D000069547', 'term': 'Cobicistat'}, {'id': 'D065819', 'term': 'Voriconazole'}, {'id': 'D017828', 'term': 'Rifabutin'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, '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': 'Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2', 'description': 'All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated.\n\nAdverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1: Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 in Period 2.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 5, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once along with a single dose of VES 2 mg on Day 2 in Period 2.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 1: Voriconazole 400 mg', 'description': 'Participants received a loading dose of VOR 400 mg twice daily on Day 1 in Period 3.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 1: Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6 in Period 3.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 1: No Treatment', 'description': 'Participant was enrolled but was not dosed.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Cohort 2: Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic (PK) Parameter : AUClast of Vesatolimod (VES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '13500', 'spread': '9500', 'groupId': 'OG000'}, {'value': '61900', 'spread': '35400', 'groupId': 'OG001'}, {'value': '14600', 'spread': '11000', 'groupId': 'OG002'}, {'value': '16400', 'spread': '17900', 'groupId': 'OG003'}, {'value': '86300', 'spread': '16000', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '560', 'ciLowerLimit': '414', 'ciUpperLimit': '757', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '137', 'ciLowerLimit': '99.5', 'ciUpperLimit': '189', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'AUClast is defined as an area under the concentration versus time curve from time zero to the last quantifiable concentration.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The VES PK Analysis Set included participants who received at least 1 dose of VES and had at least 1 nonmissing PK concentration value.'}, {'type': 'PRIMARY', 'title': 'PK Parameter : AUCinf of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '17600', 'spread': '9220', 'groupId': 'OG000'}, {'value': '68000', 'spread': '36600', 'groupId': 'OG001'}, {'value': '17800', 'spread': '11600', 'groupId': 'OG002'}, {'value': '88000', 'spread': '16800', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '433', 'ciLowerLimit': '347', 'ciUpperLimit': '540', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '118', 'ciLowerLimit': '93.5', 'ciUpperLimit': '150', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'AUCinf is defined as an area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/Lambda z).\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort."}, {'type': 'PRIMARY', 'title': 'PK Parameter : Cmax of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1130', 'spread': '1020', 'groupId': 'OG000'}, {'value': '6930', 'spread': '4650', 'groupId': 'OG001'}, {'value': '1020', 'spread': '895', 'groupId': 'OG002'}, {'value': '944', 'spread': '928', 'groupId': 'OG003'}, {'value': '22200', 'spread': '7780', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '752', 'ciLowerLimit': '525', 'ciUpperLimit': '1080', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '118', 'ciLowerLimit': '80.3', 'ciUpperLimit': '172', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Cmax is defined as the maximum observed concentration of drug.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the VES PK Analysis Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'PK Parameter : %AUCexp of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '6.97', 'groupId': 'OG000'}, {'value': '6.16', 'spread': '3.91', 'groupId': 'OG001'}, {'value': '14.7', 'spread': '6.75', 'groupId': 'OG002'}, {'value': '1.92', 'spread': '0.602', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': '%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf, calculated as (\\[AUCinf-AUClast\\]/AUCinf)\\*100.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'percentage of AUCexp', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort."}, {'type': 'PRIMARY', 'title': 'PK Parameter : Tmax of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.03', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '6.00'}, {'value': '1.52', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '2.48'}, {'value': '2.50', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '3.10'}, {'value': '5.13', 'groupId': 'OG003', 'lowerLimit': '4.18', 'upperLimit': '6.07'}, {'value': '1.28', 'groupId': 'OG004', 'lowerLimit': '1.05', 'upperLimit': '1.50'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '68.5', 'ciLowerLimit': '45.5', 'ciUpperLimit': '103', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '65.4', 'ciLowerLimit': '42.5', 'ciUpperLimit': '101', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Tmax is defined as the time (observed time point) of Cmax.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the VES PK Analysis Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'PK Parameter : Clast of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.2', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '103', 'spread': '42.2', 'groupId': 'OG001'}, {'value': '74.2', 'spread': '17.4', 'groupId': 'OG002'}, {'value': '75.9', 'spread': '30.5', 'groupId': 'OG003'}, {'value': '74.3', 'spread': '27.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Clast is defined as the last observed quantifiable concentration of the drug.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the VES PK Analysis Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'PK Parameter : Tlast of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '72.0'}, {'value': '72.0', 'groupId': 'OG001', 'lowerLimit': '71.7', 'upperLimit': '96.0'}, {'value': '48.0', 'groupId': 'OG002', 'lowerLimit': '24.3', 'upperLimit': '96.0'}, {'value': '59.8', 'groupId': 'OG003', 'lowerLimit': '24.0', 'upperLimit': '95.5'}, {'value': '72.0', 'groupId': 'OG004', 'lowerLimit': '72.0', 'upperLimit': '72.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Tlast is defined as the time (observed time point) of Clast.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the VES PK Analysis Set were analyzed.'}, {'type': 'PRIMARY', 'title': 'PK Parameter : Lambda z of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0381', 'groupId': 'OG000', 'lowerLimit': '0.0310', 'upperLimit': '0.0528'}, {'value': '0.0310', 'groupId': 'OG001', 'lowerLimit': '0.0252', 'upperLimit': '0.0425'}, {'value': '0.0321', 'groupId': 'OG002', 'lowerLimit': '0.0241', 'upperLimit': '0.0561'}, {'value': '0.0442', 'groupId': 'OG004', 'lowerLimit': '0.0400', 'upperLimit': '0.0485'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Lambda z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log concentration of drug versus time curve of the drug.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'per hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort."}, {'type': 'PRIMARY', 'title': 'PK Parameter : t1/2 of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '22.3'}, {'value': '22.4', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '27.6'}, {'value': '21.6', 'groupId': 'OG002', 'lowerLimit': '12.4', 'upperLimit': '28.7'}, {'value': '15.8', 'groupId': 'OG004', 'lowerLimit': '14.3', 'upperLimit': '17.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '120', 'ciLowerLimit': '104', 'ciUpperLimit': '138', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Least-squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '111', 'ciLowerLimit': '95.4', 'ciUpperLimit': '128', 'estimateComment': 'Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 't1/2 is defined as the terminal elimination half-life.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort."}, {'type': 'PRIMARY', 'title': 'PK Parameter : CL/F of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'spread': '92.9', 'groupId': 'OG000'}, {'value': '42.4', 'spread': '28.5', 'groupId': 'OG001'}, {'value': '176', 'spread': '137', 'groupId': 'OG002'}, {'value': '69.4', 'spread': '13.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'CL/F is defined as an apparent oral clearance.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort."}, {'type': 'PRIMARY', 'title': 'PK Parameter : Vz/F of VES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3 in Period 3.'}, {'id': 'OG003', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG004', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3480', 'spread': '1530', 'groupId': 'OG000'}, {'value': '1320', 'spread': '1100', 'groupId': 'OG001'}, {'value': '4330', 'spread': '2220', 'groupId': 'OG002'}, {'value': '1560', 'spread': '86.7', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Vz/F is defined as an apparent volume of distribution of the drug.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants in the VES PK Analysis Set with available data were analyzed. Data for Cohort 2 Vesatolimod 6mg are not reported due to participant's confidentiality reasons as there was only 1 participant in this cohort."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 in Period 2.'}, {'id': 'OG002', 'title': 'Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG003', 'title': 'Cohort 1: Voriconazole 400 mg', 'description': 'Participants received a loading dose of VOR 400 mg twice daily on Day 1 in Period 3.'}, {'id': 'OG004', 'title': 'Cohort 1: Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6 in Period 3.'}, {'id': 'OG005', 'title': 'Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.'}, {'id': 'OG006', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG007', 'title': 'Cohort 2: Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.'}, {'id': 'OG008', 'title': 'Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36.4', 'groupId': 'OG003'}, {'value': '9.1', 'groupId': 'OG004'}, {'value': '9.1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '50.0', 'groupId': 'OG007'}, {'value': '50.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose date plus 30 days (up to 77 days for Cohort 1, and up to 54 days for Cohort 2)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a study drug that 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 study drug, whether or not considered related to the study drug. Adverse events may also include pretreatment or posttreatment complications that occur as a result of protocol-specified procedures, or special situations. TEAES included all AEs began on or after the study drug start date.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Safety Analysis Set were analyzed. Per planned analysis, the data for adverse events were summarized by study treatments administered in Cohorts 1 and 2 per period.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Vesatolimod 2 mg', 'description': 'Participants received a single dose of VES 2 mg on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once daily on Days 1 to 5 in Period 2.'}, {'id': 'OG002', 'title': 'Vesatolimod 2 mg + Cobicistat 150 mg', 'description': 'Participants received COBI 150 mg once along with a single dose of VES 2 mg on Day 2 in Period 2.'}, {'id': 'OG003', 'title': 'Cohort 1: Voriconazole 400 mg', 'description': 'Participants received a loading dose of VOR 400 mg twice daily on Day 1 in Period 3.'}, {'id': 'OG004', 'title': 'Cohort 1: Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice daily on Days 2 to 6 in Period 3.'}, {'id': 'OG005', 'title': 'Vesatolimod 2 mg + Voriconazole 200 mg', 'description': 'Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3.'}, {'id': 'OG006', 'title': 'Cohort 2: Vesatolimod 6 mg', 'description': 'Participants received a single dose of VES 6 mg on Day 1 in Period 1.'}, {'id': 'OG007', 'title': 'Cohort 2: Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2.'}, {'id': 'OG008', 'title': 'Vesatolimod 6 mg + Rifabutin 300 mg', 'description': 'Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '63.6', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose date plus 30 days (up to 77 days for Cohort 1, and up to 54 days for Cohort 2)', 'description': 'A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from predose at any time postdose. Data for participants with post baseline toxicity grade 1 or higher is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Safety Analysis Set with available data were analyzed. Per planned analysis, the data for adverse events were summarized by study treatments administered in Cohorts 1 and 2 per period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Vesatolimod + Cobicistat + Voriconazole', 'description': 'Participants received a single dose of vesatolimod (VES) 2 mg on Day 1 of Period 1. In Period 2, participants received cobicistat (COBI) 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2. In Period 3, participants received a loading dose of voriconazole (VOR) 400 mg twice daily on Day 1, then VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1 and a washout period of 14 to 21 days between treatments in Period 2 Day 5 and Period 3 Day 1.'}, {'id': 'FG001', 'title': 'Cohort 2: Vesatolimod + Rifabutin', 'description': 'Participants received a single dose of VES 6 mg on Day 1. In Period 2, participants received Rifabutin (RFB) 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Enrolled but never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in the United States.', 'preAssignmentDetails': '59 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Vesatolimod + Cobicistat + Voriconazole', 'description': 'Participants received a single dose of vesatolimod (VES) 2 mg on Day 1 of Period 1. In Period 2, participants received cobicistat (COBI) 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2. In Period 3, participants received a loading dose of voriconazole (VOR) 400 mg twice daily on Day 1, then VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1 and a washout period of 14 to 21 days between treatments in Period 2 Day 5 and Period 3 Day 1.'}, {'id': 'BG001', 'title': 'Cohort 2: Vesatolimod + Rifabutin', 'description': 'Participants received a single dose of VES 6 mg on Day 1. In Period 2, participants received Rifabutin (RFB) 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6. There was a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '45', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '47', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': "Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort."}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': "Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort."}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': "Data for Cohort 2 are not reported due to participants' confidentiality reasons as there were only 2 participants in this cohort."}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-12', 'size': 2415002, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-05T13:17', 'hasProtocol': True}, {'date': '2024-01-19', 'size': 4732987, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-05T13:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': "Sponsor's decision to change the clinical development plan of this molecule. This decision is not based on efficacy or safety concerns.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2022-07-11', 'resultsFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-11', 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameter : AUClast of Vesatolimod (VES)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'AUClast is defined as an area under the concentration versus time curve from time zero to the last quantifiable concentration.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : AUCinf of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'AUCinf is defined as an area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/Lambda z).\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : Cmax of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Cmax is defined as the maximum observed concentration of drug.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : %AUCexp of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': '%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf, calculated as (\\[AUCinf-AUClast\\]/AUCinf)\\*100.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : Tmax of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Tmax is defined as the time (observed time point) of Cmax.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : Clast of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Clast is defined as the last observed quantifiable concentration of the drug.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : Tlast of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Tlast is defined as the time (observed time point) of Clast.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : Lambda z of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Lambda z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log concentration of drug versus time curve of the drug.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : t1/2 of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 't1/2 is defined as the terminal elimination half-life.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : CL/F of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'CL/F is defined as an apparent oral clearance.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'PK Parameter : Vz/F of VES', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose for Cohort 1 on Period 1 Day 1, Period 2 Day 2, and Period 3 Day 3; and for Cohort 2 on Period 1 Day 1 and Period 2 Day 6', 'description': 'Vz/F is defined as an apparent volume of distribution of the drug.\n\nCohort 1 Period 1 Day 1: Day 1 from Baseline; Cohort 1 Period 2 Day 2: Up to Day 17 from Baseline; Cohort 1 Period 3 Day 3: Up to Day 44 from Baseline; Cohort 2 Period 1 Day 1: Day 1 from Baseline; Cohort 2 Period 2 Day 6: Up to Day 21 from Baseline.'}, {'measure': 'Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'First dose date up to last dose date plus 30 days (up to 77 days for Cohort 1, and up to 54 days for Cohort 2)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a study drug that 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 study drug, whether or not considered related to the study drug. Adverse events may also include pretreatment or posttreatment complications that occur as a result of protocol-specified procedures, or special situations. TEAES included all AEs began on or after the study drug start date.'}, {'measure': 'Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities', 'timeFrame': 'First dose date up to last dose date plus 30 days (up to 77 days for Cohort 1, and up to 54 days for Cohort 2)', 'description': 'A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from predose at any time postdose. Data for participants with post baseline toxicity grade 1 or higher is reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Immunodeficiency Virus Type 1 (HIV-1) Infection']}, 'referencesModule': {'references': [{'pmid': '40952649', 'type': 'DERIVED', 'citation': 'Zheng Y, Wire M, Omange RW, deVries CR, Zhang L, Chen B, Huang SSY, Cruz K, Hassman H, Osiyemi O, Rondon JC, Lim D, West S, Wen A, Wallin JJ, SenGupta D, Cai Y. The Effects of Cobicistat and Voriconazole on the Safety, Pharmacokinetics, and Pharmacodynamics of the TLR7 Agonist Vesatolimod in People with HIV. Infect Dis Ther. 2025 Nov;14(11):2535-2549. doi: 10.1007/s40121-025-01227-x. Epub 2025 Sep 15.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=GS-US-382-1587', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to learn more about the impact of cobicistat (COBI) (P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and strong cytochrome P450 enzyme \\[CYP\\]3A inhibitor), voriconazole (VOR) (strong CYP3A inhibitor), and rifabutin (RFB) (moderate CYP3A inducer) on the study drug, vesatolimod (VES), in people with HIV-1 on antiretroviral therapy (ART).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* On an antiretroviral therapy (ART) regimen for at least 6 consecutive months, with no change in the ART regimen within 2 months prior to screening. Permitted ARTs are as follows:\n\n * Cohort 1: A regimen of (bictegravir \\[BIC\\], dolutegravir \\[DTG\\], raltegravir \\[RAL\\], or doravirine \\[DOR\\]) plus Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Examples of acceptable regimens include BIC/emtricitabine/tenofovir, DTG/ abacavir (ABC)/3TC, DTG/3TC, DTG + emtricitabine/tenofovir, or DOR/3TC/tenofovir\n * Cohort 2: A DTG-based regimen is required (DTG/ABC/3TC), (DTG/3TC), or (DTG + NRTIs)\n* Plasma HIV-1 RNA levels less than 50 copies/mL at screening\n* Have normal hematologic function with an absolute neutrophil count greater than or equal to 1.5 × 10\\^9/L, platelets greater than or equal to 150 × 10\\^9/L; hemoglobin greater than or equal to 10.5 g/dL for females and greater than or equal to 11.5 g/dL for males\n* Clusters of differentiation (CD) 4 T cell count greater than or equal to 350 cells/μL\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN) and total bilirubin less than or equal to 1.5 mg/dL, or normal direct bilirubin and creatinine less than or equal to 1.25 x ULN\n* Have a calculated creatinine clearance (CLcr) of at least 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening and upon admission\n* Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception\n* Must be willing and able to comply with all study requirements and available to complete the study schedule of assessments\n* In the judgment of the investigator, be in good general health, based on review of the results from a screening visit\n\nKey Exclusion Criteria:\n\n* Have received any study drug within 30 days prior to study dosing\n* Participation in any other clinical study (including observation studies) without prior approval from the sponsor is prohibited while participating in this study\n* Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual compliance or individual safety, or a positive drug or alcohol test at screening or baseline\n* No Evidence of chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] and/or positive HBV core antibody with positive reflex HBV DNA polymerase chain reaction (PCR)). Note: positive HBV core antibody with negative reflex HBV DNA PCR results are acceptable\n* No Evidence of active hepatitis C virus (HCV) infection (defined as positive hepatitis C antibody and HCV RNA above lower limit of quantitation). Note: positive anti-HCV antibody and negative HCV PCR results are acceptable\n* Acute febrile illness within 35 days prior to Day 1\n* Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study\n* Received any vaccine or immunomodulatory medication within 4 weeks prior to screening. Elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study will require prior approval from the sponsor\n\n * Coronavirus disease of 2019 (COVID-19) vaccinations are allowed, with the requirement that they should not be administered within 7 ± 2 days of receiving VES\n* Have a history of any of the following:\n\n * Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria\n * Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)\n * Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients\n * Autoimmune disease\n * Significant cardiac disease or a family history of long QT syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years\n * Syncope, palpitations, or unexplained dizziness\n * Implanted defibrillator or pacemaker\n * Liver disease, including Gilbert syndrome\n * Severe peptic ulcer disease requiring prolonged (≥ 6 months) medical treatment\n * Medical or surgical treatment that permanently altered gastric absorption (eg, gastric or intestinal surgery). A history of cholecystectomy is not exclusionary\n* Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with individual treatment, assessment, or compliance with the protocol\n* For Cohort 1, individuals with CYP2C19 genotype of CYP2C19\\*2/\\*2, CYP2C19\\*2/\\*3, or CYP2C19\\*3/\\*3\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05458102', 'briefTitle': 'Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1, Open-label, Multicohort Study to Evaluate the Impact of Inhibitors and Inducers of Cytochrome P450 Enzyme (CYP)3A and/or P-glycoprotein (P-gp) on the Pharmacokinetics (PK) of Vesatolimod (VES) in Virologically Suppressed Adults With HIV-1 on Antiretroviral Therapy (ART)', 'orgStudyIdInfo': {'id': 'GS-US-382-1587'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Vesatolimod + Cobicistat + Voriconazole', 'description': 'Participants will receive a single dose of vesatolimod (VES) 2 mg on Day 1 of Period 1. In Period 2, participants will receive cobicistat (COBI) 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2. In Period 3, participants will receive a loading dose of voriconazole (VOR) 400 mg twice daily on Day 1, then VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3. There will be a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1 and a washout period of 14 to 21 days between treatments in Period 2 Day 5 and Period 3 Day 1.', 'interventionNames': ['Drug: Vesatolimod', 'Drug: Cobicistat', 'Drug: Voriconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Vesatolimod + Rifabutin', 'description': 'Participants will receive a single dose of VES 6 mg on Day 1. In Period 2, participants will receive Rifabutin (RFB) 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6. There will be a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1.', 'interventionNames': ['Drug: Vesatolimod', 'Drug: Rifabutin']}], 'interventions': [{'name': 'Vesatolimod', 'type': 'DRUG', 'otherNames': ['GS-9620'], 'description': 'Administered orally', 'armGroupLabels': ['Cohort 1: Vesatolimod + Cobicistat + Voriconazole', 'Cohort 2: Vesatolimod + Rifabutin']}, {'name': 'Cobicistat', 'type': 'DRUG', 'otherNames': ['Tybost®'], 'description': 'Administered orally', 'armGroupLabels': ['Cohort 1: Vesatolimod + Cobicistat + Voriconazole']}, {'name': 'Voriconazole', 'type': 'DRUG', 'otherNames': ['Vfend®'], 'description': 'Administered orally', 'armGroupLabels': ['Cohort 1: Vesatolimod + Cobicistat + Voriconazole']}, {'name': 'Rifabutin', 'type': 'DRUG', 'otherNames': ['Mycobutin®'], 'description': 'Administered orally', 'armGroupLabels': ['Cohort 2: Vesatolimod + Rifabutin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Research, LLC.', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami, LLC.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33147', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Pharma, CR, LLC.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Research Institute, P.A.', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '08054', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}