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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of radiolabeled BMS-986165 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is PK exposure that will be determined from plasma concentration versus time | Day 1 to Day 13 | |
| Urinary/fecal TRA (Total radioactivity) recovery data | Day 1 to Day 13 | |
| PK terminal elimination half-life data (T-HALF) | Day 1 to Day 13 | |
| PK apparent total body clearance (CL/F) | Day 1 to Day 13 | |
| PK apparent volume of distribution (Vz/F) | Day 1 to Day 13 | |
| PK time of maximum observed plasma concentration (Tmax) | Day 1 to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include the incidence of adverse events (AEs) | Day 1 to Day 13 | |
| Safety endpoints include the results of electrocardiogram tests (ECGs) | Day 1 to Day 13 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Madison Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| Safety endpoints include the results of vital signs |
| Day 1 to Day 13 |
| Safety endpoints include the results of physical exams | Day 1 to Day 13 |
| Safety endpoints include the results of clinical laboratory tests | Day 1 to Day 13 |