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Completed

NCT Number: NCT03981094

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

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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Salt Lake

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986278

Drug

suspension

pirfenidone

Drug

capsule

Primary outcomes

  1. Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination

    Time frame: 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

    Time frame: 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

    Time frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)

Secondary outcomes

  1. Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 10, 2019
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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