Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of BMS-986322 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986322 | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed in plasma/whole blood concentration (Cmax) | Up to day 17 | |
| Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to day 17 | |
| Area under the plasma/whole blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to day 17 | |
| Time of maximum observed in plasma/whole blood concentration (T-max) | Up to day 17 | |
| Terminal elimination half-life (T-HALF) | Up to day 17 | |
| Apparent total body clearance (CL/F) | Up to day 17 | |
| Apparent volume of distribution of terminal phase (Vz/F) | Up to day 17 | |
| Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF)) | Up to day 17 | |
| Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF) | Up to day 17 | |
| Total amount of radioactivity recovered in urine (UR) | Up to day 17 | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to day 47 | |
| Number of participants with serious adverse events (SAEs) | Up to day 47 | |
| Number of participants with AEs leading to discontinuation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
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-andresearch/ disclosure-commitment.html
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percent of total amount of radioactivity recovered in urine (%UR) |
| Up to day 17 |
| Total amount of radioactivity recovered in feces (FR) | Up to day 17 |
| Percent of total amount of radioactivity recovered in feces (%FR) | Up to day 17 |
| Total amount of radioactivity recovered in urine and feces combined (RTotal) | Up to day 17 |
| Percent of total amount of radioactivity recovered in all excreta (%Total) | Up to day 17 |
| Up to day 47 |
| Number of participants with vital sign abnormalities | Up to day 17 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to day 17 |
| Number of participants with clinically significant physical examination findings | Up to day 17 |
| Number of participants with clinical laboratory abnormalities | Up to day 17 |