A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants

Study Overview
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Brief Summary
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An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.

Official Title
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Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: BMS-986141


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive. BMI of 20.0 to 38.0 kg/m2 inclusive Participants who a history of normal renal function Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Exclusion Criteria: Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator. History of recurrent dizziness or fall risk within 4 weeks of study drug administration History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura) Other protocol defined exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild Hepatic Impairment Subjects<br>Subjects given an oral dose of BMS-986141. | Drug: BMS-986141<br> <br> |
| Experimental: Moderate Hepatic Impairment Subjects<br>Subjects given an oral dose of BMS-986141. | Drug: BMS-986141<br> <br> |
| Experimental: Healthy Subjects<br>Subjects given an oral dose of BMS-986141. | Drug: BMS-986141<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) |