Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

Completed · Phase 1

Conditions studied: Healthy

In brief

To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)

Key facts

Study ID

NCT03930602

Run by

Bristol-Myers Squibb

People needed

16

Starts

2019-05-01

Expected to finish

2019-05-27

Last updated by the study team

2021-11-17

Who can join

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

You may qualify if…

• Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.
• Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.
• Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

You may not qualify if…

• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,
• Any major surgery within 4 weeks of study drug administration
• Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

Where it is running

• ICON Plc (PRA Health Sciences) — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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