A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.

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 kidney 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 Renal Function and Participants With Mild, Moderate, and Severe Renal Impairment and in Participants With End-Stage Renal Disease (ESRD) on Hemodialysis

Conditions
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Renal Impairment, Healthy Volunteer

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: Participants must be judged to be in good health in the opinion of the investigator OR participant has a stable disease (eg, hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control (ie, no changes in medication within 30 days prior to study drug administration) Stable renal impairment, defined as no clinically significant change in disease status, as documented by the participant's most recent eGFR assessment; eGFR must not vary more than 30% from screening to Day -1 to confirm stable renal function, and the renal impairment must be expected by the investigator not to change significantly during the next 3 months Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥50 kg, at screening 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 Have a history of cancer (malignancy) with the following exceptions: (1) subjects with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) subjects with other malignancies that 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 History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening 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: Normal renal function<br>Single dose | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Mild renal disease<br>Single dose | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Moderate renal failure<br>Single dose | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Severe renal failure<br>Single dose | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: End-stage renal disease requiring dialysis<br>Two single doses administered with washout | 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 45 days | 
| Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations |  | Approximately 45 days |