An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

Study Overview
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Brief Summary
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The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.

Official Title
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An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS-986165 in Participants With Normal Hepatic Function and Participants With Mild, Moderate and Severe Hepatic Impairment

Conditions
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Liver Dysfunction, Healthy Volunteers

Intervention / Treatment
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* Drug: BMS-986165


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 mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.73 m2 for participants 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 History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal liver function<br>Single dose | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Mild liver impairment<br>Single dose | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Moderate liver impairment<br>Single dose | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Severe liver impairment<br>Single dose | Drug: BMS-986165<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Approximately 9 days | 
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] |  | Approximately 9 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] |  | Approximately 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation |  | Approximately 44 days | 
| Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations |  | Approximately 44 days |