A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment

Study Overview
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Brief Summary
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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

Official Title
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An Open-label, Two-Part, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Hepatic Impairment

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: BMS-986263


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: BMI ≥ 18 kg/m^2 and weight ≥ 50 kg at screening (BMI = weight [kg]/height [m^2]). Participants with normal hepatic function as judged by the investigator Participants with hepatic impairment as judged by the investigator 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 participant. Any major surgery within 4 weeks of study drug administration Previous exposure to BMS-986263 Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Mild Hepatic Impairment<br>Part 1 | Drug: BMS-986263<br>* Single Dose<br>|
| Experimental: Group B: Moderate Hepatic Impairment<br>Part 1 | Drug: BMS-986263<br>* Single Dose<br>|
| Experimental: Group C: Severe Hepatic Impairment<br>Part 2 | Drug: BMS-986263<br>* Single Dose<br>|
| Experimental: Group D: Normal Hepatic function (control group)<br>Part 1 | Drug: BMS-986263<br>* Single Dose<br>|
| Experimental: Group E: Normal Hepatic Function (optional, control group)<br>Part 2 | Drug: BMS-986263<br>* Single Dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 |