Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effects of single and multiple oral doses of BMS-986331 versus placebo in healthy participants and healthy Japanese participants.

Key facts

Study ID

NCT04444050

Run by

Bristol-Myers Squibb

People needed

48

Starts

2020-06-23

Expected to finish

2021-05-19

Last updated by the study team

2022-10-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
• A body mass index of 18 - 32 kg/m2, inclusive
• Women and men must agree to follow specific methods of contraception, if applicable
• For J-MAD Part 3
• Must be Japanese (both biological parents are ethnically Japanese)

You may not qualify if…

• Women who are of childbearing potential
• Women who are pregnant or breastfeeding
• Any significant acute or chronic medical illness
• Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
• Any surgery within 12 weeks of study drug administration
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0001 — Anaheim, California, United States
• ICON (LPRA) - Lenexa — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.