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

NCT03981094 | Completed Phase 1 FDA Drug

• 1 other identifier: IM027-041
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (15)

• 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)

Study Arms (3)

BMS-986278

EXPERIMENTAL

Drug: BMS-986278

Pirfenidone

EXPERIMENTAL

Drug: Pirfenidone

BMS-986278 + Pirfenidone

EXPERIMENTAL

Drug: BMS-986278; Drug: Pirfenidone

Interventions

BMS-986278 DRUG

suspension

BMS-986278; BMS-986278 + Pirfenidone

Pirfenidone DRUG

capsule

BMS-986278 + Pirfenidone; Pirfenidone

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent.
• Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PRA Health Sciences - Salt Lake

Salt Lake City, Utah, 84124, United States

Location

Related Links

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

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 10, 2019
• Study Start: May 10, 2019
• Primary Completion: July 27, 2019
• Study Completion: July 30, 2019
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

US (1)