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The purpose of this study is to evaluate the excretion pathway of orally administered [14C]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-BMS-986196 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-BMS-986196 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax) | Up to Day 15 | |
| TRA: Time of Cmax (Tmax) | Up to Day 15 | |
| TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Up to Day 15 | |
| TRA: Amount of radioactivity recovered in urine (UR) | Up to Day 15 | |
| TRA: Amount of radioactivity recovered in feces (FR) | Up to Day 15 | |
| TRA: Amount of radioactivity recovered in bile (BR) | Up to 14 hours post dose | |
| TRA: Percent of administered dose recovered in urine (%UR) | Up to Day 15 | |
| TRA: Percent of administered dose recovered in feces (%FR) | Up to Day 15 | |
| TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total) | Up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Up to Day 15 | |
| Tmax | Up to Day 15 | |
| 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 |
|---|---|---|---|---|---|---|
| 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 |
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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 Day 15 |
| Number of Participants with Adverse Events (AEs) | Up to Day 29 |
| Number of Participants with Serious AEs (SAEs) | Up to Day 29 |
| Number of Participants with AEs Leading to Discontinuation | Up to Day 29 |
| Number of Participants with Vital Sign Abnormalities | Up to Day 15 |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Up to Day 15 |
| Number of Participants with Physical Examination Abnormalities | Up to Day 15 |
| Number of Participants with Clinical Laboratory Abnormalities | Up to Day 15 |