Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 Japan...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04444050
Start Date
June 23 2020
End Date
May 19 2021
Last Update
October 20 2022
Active Locations (2)
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1
Local Institution - 0001
Anaheim, California, United States, 92801
2
ICON (LPRA) - Lenexa
Lenexa, Kansas, United States, 66219