A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03981094
• Date of registration: 21/05/2019
• Prospective Registration: No
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants
• Scientific title: An Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy Participants
• Date of first enrolment: May 10, 2019
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03981094
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis (IPF)

Intervention(s)

Drug: Pirfenidone

Drug: BMS-986278

Primary Outcome(s)

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 [Time Frame: 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 [Time Frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)]

Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination [Time Frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)]

Secondary Outcome(s)

Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone [Time Frame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)]

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Up to Day 5 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Up to Day 8 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 [Time Frame: 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 [Time Frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)]

Secondary ID(s)

IM027-041

Source(s) of Monetary Support

Please refer to primary and secondary sponsors