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 : May 15, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis (IPF) | Drug: BMS-986278 Drug: Pirfenidone | Phase 1 |
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 10, 2019 |
Actual Primary Completion Date : | July 27, 2019 |
Actual Study Completion Date : | July 30, 2019 |

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 |
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]

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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 |
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.

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
United States, Utah | |
PRA Health Sciences - Salt Lake | |
Salt Lake City, Utah, United States, 84124 |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03981094 |
Other Study ID Numbers: |
IM027-041 |
First Posted: | June 10, 2019 Key Record Dates |
Last Update Posted: | May 15, 2020 |
Last Verified: | May 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias 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 |