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

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

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

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: BMS-986278; Drug: Pirfenidone

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • PRA Health Sciences - Salt Lake

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986278	Drug: BMS-986278; suspension
Experimental: Pirfenidone	Drug: Pirfenidone; capsule
Experimental: BMS-986278 + Pirfenidone	Drug: BMS-986278; suspension; Drug: Pirfenidone; capsule

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): July 27, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Pirfenidone
• Other Study ID Numbers: IM027-041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No