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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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

Key facts

Study ID: NCT04055506
Run by: Bristol-Myers Squibb
People needed: 16
Starts: 2019-08-14
Expected to finish: 2019-09-21
Last updated by the study team: 2020-06-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

PRA Health Sciences - Salt Lake — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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