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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Adult

Treatments: Drug: BMS-986142; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02257151

IM006-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 118 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 2 patient groups

Group 1: BMS-986142 or placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BMS-986142

Group 2: BMS-986142 or placebo

Experimental group

Description:

BMS-986142 or placebo Multiple dose oral Solution as specified

Treatment:

Drug: Placebo

Drug: BMS-986142