A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: Ritonavir

Drug: BMS-986165

Study type

Interventional

Funder types

Industry

Identifiers

IM011-087

Details and patient eligibility

About

The Study of Cytochrome P450 1A2 Induction by Ritonavir on the drug effects of BMS-986165 in Healthy Participants

Enrollment

16 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.732 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic onadotropin) within 24 hours prior to the start of study treatment.
Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening.

Exclusion criteria

Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
Prisoners or participants who are involuntarily incarcerated
Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease