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

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ClinicalTrials.gov Identifier: NCT03981094
Recruitment Status : Completed
First Posted : June 10, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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).
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 6, 2019
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Pirfenidone

Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981094


Locations
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United States, Utah
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03981094     History of Changes
Other Study ID Numbers: IM027-041
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Pirfenidone
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents