A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Other: Placebo for BMS-986322
- Registration Number
- NCT05546151
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort J2 BMS-986322 - Cohort J1 Placebo for BMS-986322 - Cohort J1 BMS-986322 - Cohort J2 Placebo for BMS-986322 - Cohort J3 BMS-986322 - Cohort J3 Placebo for BMS-986322 -
- Primary Outcome Measures
Name Time Method 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 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 clinical laboratory abnormalities Up to 7 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Anaheim Clinical Trials Llc
🇺🇸Anaheim, California, United States