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The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986446 in healthy participants including healthy participants of Japanese ethnicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986446 | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986446 | Drug | Specified dose on specified days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to Day 85 | |
| Number of participants with vital sign abnormalities | Up to Day 85 | |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 85 | |
| Number of participants with physical examination abnormalities | Up to Day 85 | |
| Number of participants with body weight abnormalities | Up to Day 85 | |
| Number of participants with clinical laboratory abnormalities | Up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 85 | |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 85 | |
| Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)] |
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Inclusion Criteria:
Exclusion Criteria:
Note: 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 |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Cypress | California | 90630 | 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 Myer 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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| Other |
Specified dose on specified days |
|
| Up to Day 85 |
| Number of participants with anti-drug antibody (ADA) | Up to Day 85 |
| Geometric mean ratios of Cmax | Up to Day 85 |
| Geometric mean ratios of [AUC(0-T)] | Up to Day 85 |
| Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Up to Day 85 |