Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Drug: BMS-986331Other: Placebo, Matching BMS-986331
- Registration Number
- NCT04444050
- Lead Sponsor
- Bristol-Myers Squibb
- 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 Japanese participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- 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)
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 SAD: Panel 5 BMS-986331 - Part 1 SAD: Panel 4 Placebo, Matching BMS-986331 - Part 1 SAD: Panel 4 BMS-986331 - Part 1 Single Ascending Dose (SAD): Panel 1 BMS-986331 - Part 1 Single Ascending Dose (SAD): Panel 1 Placebo, Matching BMS-986331 - Part 1 SAD: Panel 2 BMS-986331 - Part 1 SAD: Panel 2 Placebo, Matching BMS-986331 - Part 1 SAD: Panel 3 BMS-986331 - Part 1 SAD: Panel 3 Placebo, Matching BMS-986331 - Part 2 Multiple Ascending Dose (MAD): Panel 1 Placebo, Matching BMS-986331 - Part 2 MAD: Panel 2 BMS-986331 - Part 2 MAD: Panel 2 Placebo, Matching BMS-986331 - Part 2 MAD: Panel 3 BMS-986331 - Part 1 SAD: Panel 5 Placebo, Matching BMS-986331 - Part 1 SAD: Panel 6 BMS-986331 - Part 1 SAD: Panel 6 Placebo, Matching BMS-986331 - Part 1 SAD: Optional Split-dose Panel BMS-986331 - Part 1 SAD: Optional Split-dose Panel Placebo, Matching BMS-986331 - Part 2 Multiple Ascending Dose (MAD): Panel 1 BMS-986331 - Part 2 MAD: Panel 3 Placebo, Matching BMS-986331 - Part 2 MAD: Panel 4 BMS-986331 - Part 2 MAD: Panel 4 Placebo, Matching BMS-986331 - Part 2 MAD: Optional (to be determined) Panel BMS-986331 - Part 2 MAD: Optional (to be determined) Panel Placebo, Matching BMS-986331 - Part 3 MAD in Japanese Participants (J-MAD): Panel 1 BMS-986331 - Part 3 MAD in Japanese Participants (J-MAD): Panel 1 Placebo, Matching BMS-986331 - Part 3 J-MAD: Panel 2 BMS-986331 - Part 3 J-MAD: Panel 2 Placebo, Matching BMS-986331 - Part 3 J-MAD: Panel 3 BMS-986331 - Part 3 J-MAD: Panel 3 Placebo, Matching BMS-986331 - Part 3 J-MAD: Optional (to be determined) Panel BMS-986331 - Part 3 J-MAD: Optional (to be determined) Panel Placebo, Matching BMS-986331 -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 13 months Number of participants with clinical laboratory abnormalities Up to 46 days Number of participants with vital sign abnormalities Up to 46 days Number of participants with electrocardiogram (ECG) abnormalities Up to 46 days
- Secondary Outcome Measures
Name Time Method Time to reach Cmax in plasma (Tmax) Up to 17 days Maximum plasma concentration (Cmax) Up to 17 days Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)] Up to 17 days
Trial Locations
- Locations (2)
Local Institution - 0001
🇺🇸Anaheim, California, United States
ICON (LPRA) - Lenexa
🇺🇸Lenexa, Kansas, United States