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

Study Overview
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Brief Summary
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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

Official Title
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An Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy Participants

Conditions
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Idiopathic Pulmonary Fibrosis (IPF)

Intervention / Treatment
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* Drug: BMS-986278
* Drug: Pirfenidone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986278<br> | Drug: BMS-986278<br>* suspension<br>|
| Experimental: Pirfenidone<br> | Drug: Pirfenidone<br>* capsule<br>|
| Experimental: BMS-986278 + Pirfenidone<br> | Drug: BMS-986278<br>* suspension<br>Drug: Pirfenidone<br>* capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) |