A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects

Study Overview
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Brief Summary
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This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.

Official Title
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A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: BMS-986147
* Drug: Placebo matching BMS-986147


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 men and women, ages 18 to 45 years Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations Women of child bearing potential are eligible for enrollment. Women must have a negative pregnancy test Exclusion Criteria: Evidence of organ dysfunction Any significant acute or chronic medical illness Inability to: tolerate oral medications, be venipunctured

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A1: BMS-986147 or Placebo matching BMS-986147<br>Single oral dose as specified | Drug: BMS-986147<br> <br> Drug: Placebo matching BMS-986147<br> <br> |
| Placebo Comparator: A2: BMS-986147 or Placebo matching BMS-986147<br>Single oral dose as specified | Drug: BMS-986147<br> <br> Drug: Placebo matching BMS-986147<br> <br> |
| Placebo Comparator: A3: BMS-986147 or Placebo matching BMS-986147<br>Single oral dose as specified | Drug: BMS-986147<br> <br> Drug: Placebo matching BMS-986147<br> <br> |
| Active Comparator: B1: BMS-986147 or Placebo matching BMS-986147<br>Daily oral dose as specified | Drug: BMS-986147<br> <br> Drug: Placebo matching BMS-986147<br> <br> |
| Active Comparator: B2: BMS-986147 or Placebo matching BMS-986147<br>Daily oral dose as specified | Drug: BMS-986147<br> <br> Drug: Placebo matching BMS-986147<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations | Adverse event (AE) | Up to 30 days post last dose of study drug | 
| Safety and tolerability of multiple oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations |  | Up to 30 days post last dose of study drug | 

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