Healthy Adult
Conditions
Keywords
Volunteers
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)
Interventions
Sponsors
Study design
Eligibility
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States