Idiopathic Pulmonary Fibrosis (IPF)
Conditions
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
Interventions
DRUGBMS-986278
suspension
DRUGPirfenidone
capsule
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
Countries
United States
Outcome results
None listed