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The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986447 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986447 | Drug | Specified dose on specified days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 59 days | |
| Number of Participants with Serious AEs (SAEs) | Up to 59 days | |
| Number of Participants with Clinical Laboratory Abnormalities | Up to 34 days | |
| Number of Participants with Vital Sign Abnormalities | Up to 35 days | |
| Number of Participants with Physical Examination Abnormalities | Up to 35 days | |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Up to 34 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 72 hours postdose | |
| Time of maximum observed plasma concentration (Tmax) | Up to 72 hours postdose | |
| Apparent terminal phase half-life (T-Half) |
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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 | 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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| Drug |
Specified dose on specified days |
|
| Up to 72 hours postdose |