An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function

Study Overview
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Brief Summary
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This is an investigational study to evaluate the experimental medication BMS-986036 in participants 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-986036 in Participants With Varying Degrees of Renal Function

Conditions
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NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: BMS-986036


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: BMI ≥ 25 and ≤ 40 kg/m2 Exclusion Criteria: Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds) Any bone trauma (fracture) or bone surgery (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status Any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration Donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration Inability to tolerate subcutaneous injections Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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>The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. | Drug: BMS-986036<br>* Specified dose on specified days<br>|
| Experimental: Moderate Renal Impairment<br>The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. | Drug: BMS-986036<br>* Specified dose on specified days<br>|
| Experimental: Severe Renal Impairment<br>The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. | Drug: BMS-986036<br>* Specified dose on specified days<br>|
| Other: Normal<br>The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. | Drug: BMS-986036<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 observed serum concentration (Cmax) of C-terminal intact BMS-986036 |  | Up to 30 days | 
| Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036 |  | Up to 30 days | 
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of C-terminal intact BMS-986036 |  | Up to 30 days | 
| Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036 |  | Up to 30 days | 
| Terminal elimination half-life (T-half) of C-terminal intact BMS-986036 |  | Up to 30 days | 
| Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036 |  | Up to 30 days | 
| Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036 |  | Up to 30 days | 
| Total renal clearance (CLR) of C-terminal intact BMS-986036 |  | Up to 30 days | 
| Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036 |  | Up to 30 days | 
| Total amount excreted into urine (Ae) of C-terminal intact BMS-986036 |  | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) of total BMS-986036 |  | Up to 30 days | 
| Time of maximum observed serum concentration (Tmax) of total BMS-986036 |  | Up to 30 days | 
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036 |  | Up to 30 days | 
| Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036 |  | Up to 30 days | 
| Terminal elimination half-life (T-half) of total BMS-986036 |  | Up to 30 days | 
| Apparent total body clearance (CLT/F) of total BMS-986036 |  | Up to 30 days | 
| Apparent volume of distribution (Vz/F) of total BMS-986036 |  | Up to 30 days | 
| Total renal clearance (CLR) of total BMS-986036 |  | Up to 30 days | 
| Amount per fraction excreted into urine (Fe) of total BMS-986036 |  | Up to 30 days | 
| Total amount excreted into urine (Ae) of total BMS-986036 |  | Up to 30 days | 
| Incidence of injection site reactions (prospective) |  | Up to 30 days | 
| Incidence of adverse events (AE) |  | Up to 30 days | 
| Incidence of serious adverse events (SAE) |  | Up to 30 days | 
| Incidence of clinically significant changes to events of special interest | Events of special interest include injection site assessment, AEs leading to discontinuation, and deaths as well as AEs related to marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiogram (ECGs), and physical examinations | Up to 30 days |