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The purpose of the study is to assess mass balance, biotransformation, and excretion of BMS-986369 following study drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986369 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986369 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity recovered in whole blood | Up to 22 days | |
| Total radioactivity recovered in plasma | Up to 22 days | |
| Total radioactivity recovered in urine | Up to 22 days | |
| Total radioactivity recovered in feces | Up to 22 days | |
| Total radioactivity recovered in vomit | Up to 22 days | |
| Maximum observed plasma concentration (Cmax) | Up to 22 days | |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) | Up to 22 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 22 days | |
| Total radioactivity recovered in whole blood to plasma ratio | Up to 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 28 days | |
| Number of participants with serious adverse events (SAEs) | Up to 28 days | |
| Number of participants with vital sign abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
Prior/Concomitant Therapy
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit - Madison | Madison | Wisconsin | 53704-2526 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
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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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| Up to 28 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 28 days |
| Number of participants with clinical laboratory test abnormalities | Up to 28 days |
| Number of participants with physical examination abnormalities | Up to 28 days |