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
Overview
- Phase
- Phase 1
- Intervention
- BMS-986322
- Conditions
- Healthy Participants
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of participants with physical examination abnormalities
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cohort J1
Intervention: BMS-986322
Cohort J1
Intervention: Placebo for BMS-986322
Cohort J2
Intervention: BMS-986322
Cohort J2
Intervention: Placebo for BMS-986322
Cohort J3
Intervention: BMS-986322
Cohort J3
Intervention: Placebo for BMS-986322
Outcomes
Primary Outcomes
Number of participants with physical examination abnormalities
Time Frame: Up to 7 weeks
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 7 weeks
Number of participants with adverse events (AEs) leading to discontinuation
Time Frame: Up to 7 weeks
Number of deaths
Time Frame: Up to 7 weeks
Number of participants with AEs
Time Frame: Up to 7 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 7 weeks
Number of participants with vital sign abnormalities
Time Frame: Up to 7 weeks
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 7 weeks
Secondary Outcomes
- 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)