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The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-BMS-986368 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-BMS-986368 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to Day 15 | |
| Time of maximum observed concentration (Tmax) | Up to Day 15 | |
| Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 15 | |
| Total Radioactivity (TRA) | Up to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to Day 36 | |
| Number of participants with Serious AEs (SAEs) | Up to Day 36 | |
| Number of participants with AEs leading to discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined incusion/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 | Madison | Wisconsin | 53704-2526 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | 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/disclosure-commitment.html
See plan description
See plan description
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| Up to Day 36 |
| 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 test abnormalities | Up to Day 30 |