A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment

Conditions
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Moderate Liver Impairment, Severe Liver Impairment

Intervention / Treatment
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* Drug: BMS-986036


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations Body mass index (BMI) of 18.0 kg/m^2 to 40.0 kg/m^2, inclusive. BMI = weight (kg)/height (m^2) Exclusion Criteria: Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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: Group A: Moderate Hepatic Impairment<br> | Drug: BMS-986036<br>* Specified dose on specified days<br>|
| Experimental: Group B: Severe Hepatic Impairment<br> | Drug: BMS-986036<br>* Specified dose on specified days<br>|
| Experimental: Group C: Normal Hepatic Function<br> | Drug: BMS-986036<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Hepatic impairment, Liver impairment, Nonalcoholic steatohepatitis (NASH)