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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03981094
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis (IPF)	Drug: BMS-986278; Drug: Pirfenidone	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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).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)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 10, 2019
• Actual Primary Completion Date: Jul 27, 2019
• Actual Study Completion Date: Jul 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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)]

2. 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)]

3. 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

1. 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)]

2. 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)]

3. 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)]

4. 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)]

5. 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)]

6. 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)]

7. 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)]

8. 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)]

9. 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)]

10. 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)]

11. 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)]

12. 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)]

13. 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)]

14. 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)]

15. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences - Salt Lake	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03981094
• Other Study ID Numbers: IM027-041
• First Posted: Jun 10, 2019
• Last Update Posted: May 15, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Pirfenidone

Study Results

No Results Posted as of May 15, 2020