Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects

Study Overview
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Brief Summary
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The main purpose of this study is to measure the amount of study drug (BMS-986189) in the blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a single dose.

Official Title
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Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects

Conditions
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Severe Sepsis

Intervention / Treatment
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* Drug: BMS-986189
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy, males and females, 18 to 55 years of age, inclusive Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive Women of childbearing potential (WOCBP) must have negative serum pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to start of study drug Exclusion Criteria: Any significant acute or chronic medical illness History of diabetes mellitus, severe hypertriglyceridemia, acute or chronic pancreatitis, pancreatic exocrine disorder History of autoimmune disease Any known skin condition that would affect subcutaneous dosing Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV -1 and HIV -2 antibody Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986189<br>Specified Dose on Specified Day | Drug: BMS-986189<br> <br> |
| Placebo Comparator: Placebo<br>Specified Dose on Specified Day | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) |  | Day 1 to Day 30 | 
| Time of maximum observed concentration (Tmax) |  | Day 1 to Day 30 | 
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(O-T)) |  | Day 1 to Day 30 | 
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) |  | Day 1 to Day 30 | 
| Half Life (T-HALF) |  | Day 1 to Day 30 | 
| Total Body Clearance (CLT/F) |  | Day 1 to Day 30 | 
| Apparent volume of distribution at steady state (Vss/F) |  | Day 1 to Day 30 | 
| Deaths leading to discontinuation |  | Day 1 to Day 30 | 
| Adverse events (AEs) leading to discontinuation |  | Day 1 to Day 30 | 
| Serious adverse events (SAEs) leading to discontinuation |  | Day 1 to Day 30 | 
| Lab abnormalities leading to discontinuation |  | Day 1 to Day 30 |