An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function

Study Overview
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Brief Summary
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This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.

Official Title
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A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Participants With Varying Degrees of Hepatic Impairment

Conditions
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Liver Dysfunction, Liver Insufficiency, Hepatic Failure, Myocardial Failure, Cardiac Failure, Congestive Heart Failure, Heart Decompensation

Intervention / Treatment
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* Drug: BMS-986231


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Body weight ≥ 45 kg and ≤ 120 kg and BMI ≥ 18 kg/m2 and ≤ 35 kg/m2 Heart rate ≥ 50 bpm and < 95 bpm Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment Exclusion Criteria: Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches History of migraine or cluster headaches Other protocol defined inclusion/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<br>Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points | Drug: BMS-986231<br>* Intravenous (IV) administration<br>|
| Experimental: Moderate hepatic impairment<br>Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points | Drug: BMS-986231<br>* Intravenous (IV) administration<br>|
| Experimental: Severe hepatic impairment<br>Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points | Drug: BMS-986231<br>* Intravenous (IV) administration<br>|
| Experimental: Normal hepatic function<br>Based on Hepatic Function Impairment as defined by the investigator | Drug: BMS-986231<br>* Intravenous (IV) administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration |  | Up to 2 days | 
| AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration |  | Up to 2 days | 
| Maximum plasma concentration (Cmax) |  | Up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AE) |  | Up to 33 days | 
| Incidence of serious adverse events (SAE) |  | Up to 33 days | 
| Incidence of Laboratory Test Result Abnormalities |  | Up to 11 days | 
| Clearance (CL) derived from plasma concentration |  | Up to 2 days | 
| Terminal elimination half-life (t1/2) derived from plasma concentration |  | Up to 2 days | 
| Time of maximum observed plasma concentration (Tmax) |  | Up to 2 days | 
| Terminal elimination phase rate constant (λz) derived from plasma concentration |  | Up to 2 days | 
| Volume of distribution during terminal phase (Vz) derived from plasma concentration |  | Up to 2 days | 
| Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration |  | Up to 2 days |