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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986278 | Experimental |
| |
| Pirfenidone | Experimental |
| |
| BMS-986278 + Pirfenidone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986278 | Drug | suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Salt Lake | Salt Lake City | Utah | 84124 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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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).
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| Pirfenidone |
| Drug |
capsule |
|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| FDA Safety Alerts and Recalls | View source |