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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

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.

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Detailed Description

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

Conditions

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Healthy Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: BMS-986142 or placebo

BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified

Group Type EXPERIMENTAL

BMS-986142

Intervention Type DRUG

Placebo

Intervention Type DRUG

Group 2: BMS-986142 or placebo

BMS-986142 or placebo Multiple dose oral Solution as specified

Group Type EXPERIMENTAL

BMS-986142

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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BMS-986142

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=weight (kg)/\[height(m)\]2

Exclusion Criteria

1. Any significant acute or chronic medical illness
2. Current or recent (within 3 months of study drug administration) gastrointestinal disease
3. Any major surgery within 4 weeks of study drug administration
4. Any gastrointestinal surgery that could impact upon the absorption of study drug
5. 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes