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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort J1 | Experimental |
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| Cohort J2 | Experimental |
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| Cohort J3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986322 | Drug | Specified dose on specified days |
|
| 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 |
| 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]) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials Llc | Anaheim | California | 92801 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html.
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| Placebo for BMS-986322 | Other | Specified dose on specified days |
|
| Day 1 and Day 14 |