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The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of [14C]BMS-986419 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]BMS-986419 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]BMS-986419 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 20 | |
| Time of maximum plasma observed concentration (Tmax) | Up to Day 20 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Up to Day 20 | |
| Total radioactivity recovered in urine (UR) | Up to Day 30 | |
| Total radioactivity recovered in feces (FR) | Up to Day 30 | |
| Total radioactivity recovered in bile (BR) | Up to Day 30 | |
| Total radioactivity recovered (Rtotal) | Up to Day 30 | |
| Percent of total radioactivity recovered (%Total) | Up to Day 30 | |
| Percent of total radioactivity recovered in urine (%UR) | Up to Day 30 | |
| Percent of total radioactivity recovered in feces (%FR) | Up to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to Day 60 | |
| Number of Participants with Serious AEs (SAEs) | Up to Day 60 | |
| Number of Participants with AEs leading to discontinuation |
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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 60 |
| Number of Participants with Vital Sign Abnormalities | Up to Day 30 |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Up to Day 30 |
| Number of Participants with Physical Examination Abnormalities | Up to Day 30 |
| Number of Participants with Clinical Laboratory Abnormalities | Up to Day 30 |