Clinical trial NCT03981094: A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants
Official title: An Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-06-10
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination
timeFrame: Up to day 5 of each period (Each period is 7 days; 3 periods total)
measure: 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
timeFrame: Up to day 5 of each period (Each period is 7 days; 3 periods total)
measure: Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton
timeFrame: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Secondary outcomes:
measure: Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation
timeFrame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
measure: Number of Participants With Clinically Significant Change in Clinical Laboratory Values
timeFrame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
measure: Number of Participants With Clinically Significant Change in Vital Signs
timeFrame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
measure: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
timeFrame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
measure: Number of Participants With Clinically Significant Change in Physical Examination
timeFrame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
measure: Volume of distribution at terminal phase (VzF) of BMS-986278 and metabolite alone or in combination with pirfenidone
timeFrame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
measure: Time of maximum observed serum concentration (Tmax) of BMS-986278 and metabolite alone or in combination with pirfenidone
timeFrame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
measure: Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone
timeFrame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
measure: Oral clearance (CL/F) of BMS-986278 and metabolite alone or in combination with pirfenidone
timeFrame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
measure: Time of maximum observed serum concentration (Tmax) of pirfenidone and metabolite alone or in combination with BMS-986278
timeFrame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
measure: Elimination half-life (T-HALF) of pirfenidone and metabolite alone or in combination with BMS-986278
timeFrame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
measure: Oral clearance (CL/F) of pirfenidone and metabolite alone or in combination with BMS-986278
timeFrame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
measure: Volume of distribution at terminal phase (VzF) Plasma Pharmokinetics of pirfenidone and metabolite alone or in combination with BMS-986278
timeFrame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
measure: Renal clearance (Clr) in Urine of pirfenidone alone or in combination with BMS-986278
timeFrame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
measure: Cumulative amount recovered in urine [Ae(0-T)] of pirfenidone alone or in combination with BMS-986278
timeFrame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences - Salt Lake
state: Utah
Study officials:
References: