An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.

Official Title
-----------------
A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BMS-986224 in Participants With Varying Degrees of Renal Function

Conditions
-----------------
Cardiac Failure, Myocardial Failure

Intervention / Treatment
-----------------
* Drug: BMS-986224


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: BMI ≥18 and ≤ 35kg/m2 Systolic blood pressure >100 mmHg Exclusion Criteria: Women of childbearing potential or women who are currently pregnant 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 Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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> | Drug: BMS-986224<br>* Specified dose on specified days<br>|
| Experimental: Mild Renal Impairment<br> | Drug: BMS-986224<br>* Specified dose on specified days<br>|
| Experimental: Moderate Renal Impairment<br> | Drug: BMS-986224<br>* Specified dose on specified days<br>|
| Experimental: Severe Renal Impairment<br> | Drug: BMS-986224<br>* Specified dose on specified days<br>|
| Experimental: End-Stage Renal Disease (ESRD)<br>ESRD participants and are on chronic hemodialysis | Drug: BMS-986224<br>* Specified dose on specified days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of BMS-986224 |  | Up to 11 days | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224 |  | Up to 11 days | 
| Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224 |  | Up to 11 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224 |  | Up to 11 days | 
| Time of maximum observed plasma concentration (Tmax) of BMS-986224 |  | Up to 11 days | 
| Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration |  | Up to 11 days | 
| Fraction of unbound drug in plasma (fu) of BMS-986224 |  | Up to 11 days | 
| Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration |  | Up to 11 days | 
| Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration |  | Up to 11 days | 
| Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224 | Part 1 only | 7 days | 
| Fraction of dose excreted in urine (Fe%) of BMS-986224 | Part 1 only | 7 days | 
| Renal clearance of BMS-986224 derived from urine concentration | Part 1 only | 7 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 |  | Up to 41 days | 
| Maximum observed plasma concentration (Cmax) of metabolite |  | Up to 11 days | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite |  | Up to 11 days | 
| Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite |  | Up to 11 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite |  | Up to 11 days | 
| Time of maximum observed plasma concentration (Tmax) of metabolite |  | Up to 11 days | 
| Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration |  | Up to 11 days | 
| Metabolite-to-parent (MR) ratio for cMax |  | Up to 11 days | 
| Metabolite-to-parent (MR) ratio for AUC(0-T) |  | Up to 11 days | 
| Metabolite-to-parent (MR) ratio for AUC(0-72) |  | Up to 11 days | 
| Metabolite-to-parent (MR) ratio for AUC(INF) |  | Up to 11 days | 
| Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests |  | Up to 11 days |