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Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Oral Dose of BMS-986205 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986205 | Drug | Carbon 14 tagged BMS-986205 |
|
| 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 28 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 28 days |
| Half-Life (T-HALF) | Measured by plasma concentrations | up to 28 days |
| Total Body Clearance (CLT) | Measured by plasma concentrations | up to 28 days |
| Volume of Distribution during Terminal Elimination Phase (Vz/F) | Measured by plasma concentrations | up to 28 days |
| Time to Maximum Observed Concentration (Tmax) | Measured by plasma concentrations | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Measured by investigator assessment | up to 28 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
Male inclusion only
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| Name | Affiliation | Role |
|---|---|---|
| Bristol- Myers Squibb | Bristol-Myers Squibb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc. | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000630574 | linrodostat |
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| up to 28 days |
| Results of vital sign measurements | Measured by investigator assessment | up to 28 days |
| Results of clinical laboratory tests | Measured by investigator assessment | up to 28 days |