A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.

Official Title
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A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986322
* Other: Placebo for BMS-986322


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be of Japanese descent (both biological parents are ethnically Japanese). In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations. Women should be of non-childbearing potential. Exclusion Criteria: 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 major surgery within 90 days 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: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort J1<br> | Drug: BMS-986322<br>* Specified dose on specified days<br>Other: Placebo for BMS-986322<br>* Specified dose on specified days<br>|
| Experimental: Cohort J2<br> | Drug: BMS-986322<br>* Specified dose on specified days<br>Other: Placebo for BMS-986322<br>* Specified dose on specified days<br>|
| Experimental: Cohort J3<br> | Drug: BMS-986322<br>* Specified dose on specified days<br>Other: Placebo for BMS-986322<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 serious adverse events (SAEs) |  | Up to 7 weeks | 
| Number of participants with adverse events (AEs) leading to discontinuation |  | Up to 7 weeks | 
| Number of deaths |  | Up to 7 weeks | 
| Number of participants with AEs |  | Up to 7 weeks | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 7 weeks | 
| Number of participants with vital sign abnormalities |  | Up to 7 weeks | 
| Number of participants with physical examination abnormalities |  | Up to 7 weeks | 
| Number of participants with clinical laboratory abnormalities |  | Up to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Day 1 and Day 14 | 
| Time of maximum observed plasma concentration (Tmax) |  | Day 1 and Day 14 | 
| Area under the concentration-time curve within a dosing interval (AUC[TAU]) |  | Day 1 and Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986322, Japanese descent