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The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Mild Hepatic Impairment | Experimental | Part 1 |
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| Group B: Moderate Hepatic Impairment | Experimental | Part 1 |
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| Group C: Severe Hepatic Impairment | Experimental | Part 2 |
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| Group D: Normal Hepatic function (control group) | Experimental | Part 1 |
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| Group E: Normal Hepatic Function (optional, control group) | Experimental | Part 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986263 | Drug | Single Dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection | Day 1 to Day 31 | |
| Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection | Day 1 to Day 31 | |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection | Day 1 to Day 31 | |
| Total body clearance (CL) of components of BMS-986263 for injection | Day 1 to Day 31 | |
| Volume of distribution (Vz) of components of BMS-986263 for injection | Day 1 to Day 31 | |
| Terminal elimination half-life (T-Half) of components of BMS-986263 for injection | Day 1 to Day 31 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 31 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 59 days or up to 30 days after dosing (whichever is longer) | |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
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 |
|---|---|---|---|---|---|---|
| The Texas Liver Institute | San Antonio | Texas | 78215 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Incidence of AEs leading to discontinuation |
| Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer). |
| Number of participants with abnormalities in clinical laboratory assessments | Up to 59 days |
| Number of participants with vital sign abnormalities | Up to 59 days |
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities | Up to 59 days |
| Number of participants with physical examination abnormalities | Up to 59 days |
| FDA Safety Alerts and Recalls | View source |