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The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Moderate Hepatic Impairment | Experimental |
| |
| Group B: Severe Hepatic Impairment | Experimental |
| |
| Group C: Normal Hepatic Function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986036 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 29 days | |
| Time of maximum observed plasma concentration (Tmax) | Up to 29 days | |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) | Up to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 31 days | |
| Number of participants with clinical laboratory abnormalities | Up to 31 days | |
| Number of participants with vital sign abnormalities |
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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 |
|---|---|---|---|---|---|---|
| Local Institution - 0002 | Miami | Florida | 33014 | United States | ||
| Local Institution |
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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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| Up to 31 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 31 days |
| Number of participants with physical examination abnormalities | Up to 31 days |
| Maximum observed plasma concentration (Cmax) | Up to 29 days |
| Time of maximum observed plasma concentration (Tmax) | Up to 29 days |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T)) | Up to 29 days |
| Orlando |
| Florida |
| 32809 |
| United States |
| Local Institution - 0001 | San Antonio | Texas | 78215 | United States |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000630067 | Pegbelfermin |
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