A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT05684289
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of BMS-986278 in healthy adult participants and Japanese participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
- Participants in the Japanese cohort (Part 2) must be first generation Japanese (born in Japan, not living outside of Japan > 10 years, both parents ethnically Japanese).
- Body mass index (BMI) of 18.0 kilogram (kg)/meter (m)^2 through 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2.
- Body weight ≥ 50 kg for males and ≥ 45 kg for females.
Exclusion Criteria
- Any significant acute or chronic medical illness.
- Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion.
- Any major surgery within 4 weeks of first study intervention administration.
Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: BMS-986278 + Sildenafil BMS-986278 - Part 1: Placebo + Sildenafil Placebo - Part 2: Placebo Placebo - Part 1: BMS-986278 + Sildenafil Sildenafil - Part 1: Placebo + Sildenafil Sildenafil - Part 2: BMS-986278 BMS-986278 -
- Primary Outcome Measures
Name Time Method Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1) Up to 16 days Time of maximum observed plasma concentration (Tmax) (Part 2) Up to 14 days Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) (Part 2) Up to 14 days Maximum observed plasma concentration (Cmax) (Part 2) Up to 14 days
- Secondary Outcome Measures
Name Time Method Number of participants with serious adverse events (SAEs) (Part 1 and 2) 30 days after last dose Number of participants with clinical laboratory abnormalities (Part 1 and 2) 30 days after last dose AUC(0-T) (Part 1) Up to 16 days Number of participants with vital sign abnormalities (Part 1 and 2) 30 days after last dose Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2) 30 days after last dose Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1) 30 days after last dose Cmax (Part 1 and 2) Up to 16 days Number of participants with physical examination abnormalities (Part 1 and 2) 30 days after last dose Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2) Up to 14 days Tmax (Part 1) Up to 16 days Number of participants with adverse events (AEs) (Part 1 and 2) 30 days after last dose
Trial Locations
- Locations (2)
Syneos Health Clinical Research Services, Llc
🇺🇸Miami, Florida, United States
Altasciences Clinical Los Angeles, Inc
🇺🇸Cypress, California, United States