Healthy Participants
Conditions
Keywords
BMS-986278, Idiopathic Pulmonary Fibrosis (IPF), Sildenafil
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.
Interventions
DRUGBMS-986278
Specified dose on specified days
DRUGSildenafil
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1) | Up to 16 days |
| Maximum observed plasma concentration (Cmax) (Part 2) | Up to 14 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 |
Secondary
| Measure | Time frame |
|---|---|
| Cmax (Part 1 and 2) | Up to 16 days |
| Tmax (Part 1) | Up to 16 days |
| AUC(0-T) (Part 1) | Up to 16 days |
| Number of participants with adverse events (AEs) (Part 1 and 2) | 30 days after last dose |
| 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 |
| Number of participants with physical examination abnormalities (Part 1 and 2) | 30 days after last dose |
| 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 |
| Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2) | Up to 14 days |
Countries
United States
Outcome results
None listed