Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, and Pharmacokinetics of BMS-986142 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- BMS-986142
- Conditions
- Healthy Adult
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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)
Investigators
Eligibility Criteria
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)
Arms & Interventions
Group 1: BMS-986142 or placebo
BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified
Intervention: BMS-986142
Group 1: BMS-986142 or placebo
BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified
Intervention: Placebo
Group 2: BMS-986142 or placebo
BMS-986142 or placebo Multiple dose oral Solution as specified
Intervention: BMS-986142
Group 2: BMS-986142 or placebo
BMS-986142 or placebo Multiple dose oral Solution as specified
Intervention: Placebo
Outcomes
Primary Outcomes
Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142
Time Frame: 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
Time Frame: Multiple Ascending Dose (MAD) within 19 days