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

Phase 1

Completed

• Conditions: Healthy Adult
• Interventions: Drug: BMS-986142; Drug: Placebo

• Registration Number: NCT02257151
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: BMS-986142 or placebo	Placebo	BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified
Group 2: BMS-986142 or placebo	Placebo	BMS-986142 or placebo Multiple dose oral Solution as specified
Group 2: BMS-986142 or placebo	BMS-986142	BMS-986142 or placebo Multiple dose oral Solution as specified
Group 1: BMS-986142 or placebo	BMS-986142	BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wcct Global, Llc; 🇺🇸 Cypress, California, United States