A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function

Study Overview
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Brief Summary
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A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function

Detailed Description
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Recruitment temporarily on hold due to COVID-19

Official Title
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A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986259 in Participants With Varying Degrees of Renal Function

Conditions
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Renal Failure

Intervention / Treatment
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* Drug: BMS-986259


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: Participant must have renal impairment, as defined by eGFR at screening using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation No change in medications to control Chronic Kidney Disease (CKD) for at least 2 weeks prior to dosing, and if possible, during confinement in the clinical research unit (CRU), except those cleared by the investigator and Medical Monitor. Participants with normal renal function at screening, based upon the opinion of the investigator's medical evaluation. Medically well-controlled disorders (eg, stable chronic asthma, allergy) are permitted if the treatment for the disease does not interfere with the study. Women and men must use highly effective methods of contraception for the duration of treatment Exclusion Criteria: History of any significant drug allergy or drug-related Serious Adverse Events (SAE) (such as anaphylaxis or hepatotoxicity) Positive results for drugs abuse in urine/saliva Participants undergoing any method of dialysis (eg, hemodialysis, peritoneal dialysis) within the last 3 months or with anticipated need for dialysis during the study Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population Known previous exposure to BMS-986259 Other inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Arm A: Normal Renal Function<br> | Drug: BMS-986259<br>* Specified Dose on Specified Days<br>|
| Experimental: Arm B: Mild Renal Impairment<br> | Drug: BMS-986259<br>* Specified Dose on Specified Days<br>|
| Experimental: Arm C: Moderate Renal Impairment<br> | Drug: BMS-986259<br>* Specified Dose on Specified Days<br>|
| Experimental: Arm D: Severe Renal Impairment<br> | Drug: BMS-986259<br>* Specified Dose on Specified Days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum |  | Day 1 and Day 8 | 
| Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum |  | Day 1 and Day 8 | 
| Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU) |  | Day 1 and Day 8 | 
| Concentration of BMS-986259 in blood serum at 24 hours (C24) |  | Day 1 and Day 8 | 
| Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T) |  | Day 8 | 
| Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax) |  | Day 8 | 
| Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU]) |  | Day 8 | 
| Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24) |  | Day 8 | 
| Terminal elimination half-life of BMS-986259 (T-HALF) |  | Day 8 | 
| Apparent total clearance of BMS-986259 at steady-state (CLss/F) |  | Day 8 | 
| Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F) |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Non serious Adverse Events (AEs) |  | Up to 4 months | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 4 months | 
| Incidence of AEs leading to discontinuation |  | Up to 4 months | 
| Number of clinically significant changes in vital signs |  | Up to 4 months | 
| Number in clinically significant changes in Electrocardiogram (ECG) |  | Up to 4 months | 
| Number of clinically significant changes in physical examinations |  | Up to 4 months | 
| Number of clinically significant changes in clinical laboratory tests |  | Up to 4 months |