Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement of BMS-986142 in healthy subjects.

Detailed Description
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Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)

Official Title
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Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, and Pharmacokinetics of BMS-986142 in Healthy Subjects

Conditions
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Healthy Adult

Intervention / Treatment
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* Drug: BMS-986142
* Drug: 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 male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=weight (kg)/[height(m)]2 Exclusion Criteria: Any significant acute or chronic medical illness Current or recent (within 3 months of study drug administration) gastrointestinal disease Any major surgery within 4 weeks of study drug administration Any gastrointestinal surgery that could impact upon the absorption of study drug Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: BMS-986142 or placebo<br>BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified | Drug: BMS-986142<br> <br> Drug: Placebo<br> <br> |
| Experimental: Group 2: BMS-986142 or placebo<br>BMS-986142 or placebo Multiple dose oral Solution as specified | Drug: BMS-986142<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142 |  | Single Ascending Dose(SAD) within 8 days | 
| Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after multiple doses of BMS-986142 |  | Multiple Ascending Dose (MAD) within 19 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volunteers