A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function

Study Overview
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Brief Summary
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The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney 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 Subjects With Varying Degrees of Renal Function

Conditions
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Myocardial Failure, Cardiac Failure, Congestive Heart Failure, Kidney Failure, Renal Failure

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 BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2 Heart rate ≥ 50 bpm and < 95 bpm Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment No changes in medication within 30 days prior to study drug administration Exclusion Criteria: Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months History of headaches related to caffeine withdrawal History of migraine or cluster headaches Patients requiring dialysis will not be enrolled in this study 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 Renal Impairment<br>Mild renal impairment defined as eGFR 60 to <90 mL/min/1.73 m^2 | Drug: BMS-986231<br>* Intravenous infusion administration<br>|
| Experimental: Moderate renal impairment<br>Moderate renal impairment defined as eGFR 30 to <60 mL/min/1.73 m^2 | Drug: BMS-986231<br>* Intravenous infusion administration<br>|
| Experimental: Severe renal impairment<br>Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2, not requiring dialysis | Drug: BMS-986231<br>* Intravenous infusion administration<br>|
| Experimental: Normal renal function<br>Normal renal function defined as eGFR ≥90 mL/min/1.73 m^2 | Drug: BMS-986231<br>* Intravenous infusion 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) derived from plasma concentration |  | 11 days | 
| Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration |  | 11 days | 
| Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration |  | 11 days | 
| Clearance (CL) derived from plasma concentration |  | 11 days | 
| Renal clearance (CLR) derived from urine concentration |  | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AE) |  | Up to 31 days | 
| Number of serious adverse events (SAE) |  | Up to 31 days | 
| Terminal elimination half-life (t1/2) |  | Up to 36 hours | 
| Time of maximum observed plasma concentration (Tmax) |  | Up to 36 hours | 
| AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt) |  | Up to 36 hours | 
| Terminal elimination phase rate constant (λz) |  | Up to 36 hours | 
| Volume of distribution during terminal phase (Vz) |  | Up to 36 hours | 
| Fraction of administered drug excreted into urine (Fe) |  | Up to 36 hours | 
| Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast) |  | Up to 36 hours |