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Business objectives have changed.
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An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Hepatic Impairment Subjects | Experimental | Subjects given an oral dose of BMS-986141. |
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| Moderate Hepatic Impairment Subjects | Experimental | Subjects given an oral dose of BMS-986141. |
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| Healthy Subjects | Experimental | Subjects given an oral dose of BMS-986141. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986141 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986141 | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141 | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141 | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) | |
| Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141 | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation. | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) |
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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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States | ||
| Clinical Research Center |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| C000729678 | BMS-986141 |
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| Orlando |
| Florida |
| 32809 |
| United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |