A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants
Purpose
The main objectives of this study are to characterize the PK of BMS-986278 after administration of a single dose of BMS-986278 alone or in combination with pirfenidone, as well as to characterize the PK of pirfenidone after administration of a single dose of pirfenidone alone or in combination with BMS-986278
Condition
- Idiopathic Pulmonary Fibrosis (IPF)
Eligibility
- Eligible Ages
- Between 21 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Signed Informed Consent. - Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
Exclusion Criteria
- Women of child bearing potentia (WOCBP), pregnant or breastfeeding. - History of significant cardiovascular disease. - Participants who have smoked or used smoking cessation or nicotine containing products within 3 months of the first dose of study. Other protocol defined inclusion/exclusion criteria could apply.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- The study will be conducted in three periods, so that all the randomized participants receive treatment (participants receive pirfenidone only, or BMS-986278 only, or both together during each treatment period).
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BMS-986278 |
|
|
|
Experimental Pirfenidone |
|
|
|
Experimental BMS-986278 + Pirfenidone |
|
Recruiting Locations
More Details
- NCT ID
- NCT03981094
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb