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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-Blind, Placebo-Controlled Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986331 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986331
* Other: Placebo, Matching BMS-986331


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 Single Ascending Dose (SAD): Panel 1<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 1 SAD: Panel 2<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 1 SAD: Panel 3<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 1 SAD: Panel 4<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 1 SAD: Panel 5<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 1 SAD: Panel 6<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 1 SAD: Optional Split-dose Panel<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 2 Multiple Ascending Dose (MAD): Panel 1<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 2 MAD: Panel 2<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 2 MAD: Panel 3<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 2 MAD: Panel 4<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 2 MAD: Optional (to be determined) Panel<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 3 MAD in Japanese Participants (J-MAD): Panel 1<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 3 J-MAD: Panel 2<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 3 J-MAD: Panel 3<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|
| Experimental: Part 3 J-MAD: Optional (to be determined) Panel<br> | Drug: BMS-986331<br>* Specified dose on specified days<br>Other: Placebo, Matching BMS-986331<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | Up to 17 days | 
| Time to reach Cmax in plasma (Tmax) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy participants