A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants
Phase 1
Completed
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Interventions
- Registration Number
- NCT03981094
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BMS-986278 + Pirfenidone BMS-986278 - BMS-986278 + Pirfenidone Pirfenidone - Pirfenidone Pirfenidone - BMS-986278 BMS-986278 -
- Primary Outcome Measures
Name Time Method Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination Up to day 5 of each period (Each period is 7 days; 3 periods total) Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986278 and pirfenidone alone or in combinaton Up to day 5 of each period (Each period is 7 days; 3 periods total) Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton Up to day 5 of each period (Each period is 7 days; 3 periods total)
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Change in Physical Examination Up to Day 8 of Period 3 (each period is 7 days; 3 periods total) Volume of distribution at terminal phase (VzF) of BMS-986278 and metabolite alone or in combination with pirfenidone Up to Day 5 of period 3 (each period is 7 days; 3 periods total) Oral clearance (CL/F) of BMS-986278 and metabolite alone or in combination with pirfenidone Up to Day 5 of period 3 (each period is 7 days; 3 periods total) Elimination half-life (T-HALF) of pirfenidone and metabolite alone or in combination with BMS-986278 Up to Day 5 of Period 3 (each period is 7 days; 3 periods total) Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation Up to Day 8 of Period 3 (each period is 7 days; 3 periods total) Number of Participants With Clinically Significant Change in Clinical Laboratory Values Up to Day 8 of Period 3 (each period is 7 days; 3 periods total) Number of Participants With Clinically Significant Change in Vital Signs Up to Day 8 of Period 3 (each period is 7 days; 3 periods total) Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Up to Day 8 of Period 3 (each period is 7 days; 3 periods total) Time of maximum observed serum concentration (Tmax) of BMS-986278 and metabolite alone or in combination with pirfenidone Up to Day 5 of period 3 (each period is 7 days; 3 periods total) Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone Up to Day 5 of period 3 (each period is 7 days; 3 periods total) Time of maximum observed serum concentration (Tmax) of pirfenidone and metabolite alone or in combination with BMS-986278 Up to Day 5 of Period 3 (each period is 7 days; 3 periods total) Volume of distribution at terminal phase (VzF) Plasma Pharmokinetics of pirfenidone and metabolite alone or in combination with BMS-986278 Up to Day 5 of Period 3 (each period is 7 days; 3 periods total) Renal clearance (Clr) in Urine of pirfenidone alone or in combination with BMS-986278 Up to Day 5 of Period 3 (each period is 7 days; 3 periods total) Cumulative amount recovered in urine [Ae(0-T)] of pirfenidone alone or in combination with BMS-986278 Up to Day 5 of Period 3 (each period is 7 days; 3 periods total) Oral clearance (CL/F) of pirfenidone and metabolite alone or in combination with BMS-986278 Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Trial Locations
- Locations (1)
PRA Health Sciences - Salt Lake
🇺🇸Salt Lake City, Utah, United States