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An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986231 Intravenous Infusion | Experimental | A single continuous intravenous infusion of BMS-986231 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986231 | Drug | BMS-986231 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) | Measured by plasma concentrations | Up to 8 days |
| Percent of Total Radioactivity Recovered in All Excreta (% total) | Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts | Up to 8 days |
| Half-Life (T-HALF) | Measured by plasma concentrations | Up to 8 days |
| Total Body Clearance (CLT) | Measured by plasma concentrations | Up to 8 days |
| Volume of Distribution during Terminal Elimination Phase (Vz/F) | Measured by plasma concentrations | Up to 8 days |
| Time to Maximum Observed Concentration (Tmax) | Measured by plasma concentrations | Up to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Measured by investigator assessment | Up to 8 days |
| Results of electrocardiogram tests (ECGs) | Measured by investigator assessment |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Up to 8 days |
| Results of vital sign measurements | Measured by investigator assessment | Up to 8 days |
| Results of clinical laboratory tests | Measured by investigator assessment | Up to 8 days |