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

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981094
• Other study ID #: IM027-041
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: May 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 30, 2019
• Est. primary completion date: July 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

Intervention

Drug:
• BMS-986278
suspension
• Pirfenidone
capsule

Locations

Country	Name	City	State
United States	PRA Health Sciences - Salt Lake	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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