A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort J1
|
Drug: BMS-986322
Specified dose on specified days
Other: Placebo for BMS-986322
Specified dose on specified days
|
Experimental: Cohort J2
|
Drug: BMS-986322
Specified dose on specified days
Other: Placebo for BMS-986322
Specified dose on specified days
|
Experimental: Cohort J3
|
Drug: BMS-986322
Specified dose on specified days
Other: Placebo for BMS-986322
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant must be of Japanese descent (both biological parents are ethnically Japanese).
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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.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- IM032-042