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The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
| |
| Part B - Arm 1 | Experimental |
| |
| Part B - Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986365 | Drug | Specified dose on specified days |
| |
| [14C] BMS-986365 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Part A and B | Up to Day 60 |
| Time of maximum observed concentration (Tmax) | Part A and B | Up to Day 60 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Part A and B | Up to Day 60 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF)) | Part A and B | Up to Day 60 |
| Apparent terminal plasma half-life (T-HALF) | Part A and B | Up to Day 60 |
| Total body clearance (CLT) | Part A | Up to Day 15 |
| Apparent total body clearance (CLT/F) | Part A and B | Up to Day 60 |
| Mean residence time (MRT) | Part A | Up to Day 15 |
| Apparent volume of distribution (Vz) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | Part A and B | Up to Day 60 |
| Number of participants with Serious Adverse Events | Part A and B |
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Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Madison | Wisconsin | 53704 | 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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| Drug |
Specified dose on specified days. |
|
| [14C] BMS-986409 + BMS-986410 | Drug | Specified dose on specified days |
|
| [14C] BMS-986410 + BMS-986409 | Drug | Specified dose on specified days |
|
Part A
| Up to Day 15 |
| Apparent volume of distribution (Vz/F) | Part A and B | Up to Day 60 |
| Absolute bioavailability (F) | Part A | Up to Day 15 |
| Up to Day 60 |
| Number of participants with AEs leading to discontinuation | Part A and B | Up to Day 60 |
| Number of participants with Vital sign abnormalities | Part A and B | Up to Day 60 |
| Number of participants with electrocardiogram (ECG) abnormalities | Part A and B | Up to Day 60 |
| Number of participants with physical examination abnormalities | Part A and B | Up to Day 60 |
| Number of participants with clinical laboratory abnormalities | Part A and B | Up to Day 60 |