Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-31 @ 11:10 AM
Study NCT ID:
NCT03981094
Status:
COMPLETED
Last Update Posted:
2020-05-15
First Post:
2019-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093844', 'term': 'pirfenidone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-14', 'studyFirstSubmitDate': '2019-05-21', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination', 'timeFrame': 'Up to day 5 of each period (Each period is 7 days; 3 periods total)'}, {'measure': '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', 'timeFrame': 'Up to day 5 of each period (Each period is 7 days; 3 periods total)'}, {'measure': 'Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton', 'timeFrame': 'Up to day 5 of each period (Each period is 7 days; 3 periods total)'}], 'secondaryOutcomes': [{'measure': 'Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation', 'timeFrame': 'Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Number of Participants With Clinically Significant Change in Clinical Laboratory Values', 'timeFrame': 'Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Number of Participants With Clinically Significant Change in Vital Signs', 'timeFrame': 'Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)', 'timeFrame': 'Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Number of Participants With Clinically Significant Change in Physical Examination', 'timeFrame': 'Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Volume of distribution at terminal phase (VzF) of BMS-986278 and metabolite alone or in combination with pirfenidone', 'timeFrame': 'Up to Day 5 of period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Time of maximum observed serum concentration (Tmax) of BMS-986278 and metabolite alone or in combination with pirfenidone', 'timeFrame': 'Up to Day 5 of period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone', 'timeFrame': 'Up to Day 5 of period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Oral clearance (CL/F) of BMS-986278 and metabolite alone or in combination with pirfenidone', 'timeFrame': 'Up to Day 5 of period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Time of maximum observed serum concentration (Tmax) of pirfenidone and metabolite alone or in combination with BMS-986278', 'timeFrame': 'Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Elimination half-life (T-HALF) of pirfenidone and metabolite alone or in combination with BMS-986278', 'timeFrame': 'Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Oral clearance (CL/F) of pirfenidone and metabolite alone or in combination with BMS-986278', 'timeFrame': 'Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Volume of distribution at terminal phase (VzF) Plasma Pharmokinetics of pirfenidone and metabolite alone or in combination with BMS-986278', 'timeFrame': 'Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Renal clearance (Clr) in Urine of pirfenidone alone or in combination with BMS-986278', 'timeFrame': 'Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)'}, {'measure': 'Cumulative amount recovered in urine [Ae(0-T)] of pirfenidone alone or in combination with BMS-986278', 'timeFrame': 'Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis (IPF)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent.\n* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.\n\nExclusion Criteria:\n\n* Women of child bearing potentia (WOCBP), pregnant or breastfeeding.\n* History of significant cardiovascular disease.\n* Participants who have smoked or used smoking cessation or nicotine containing products within 3 months of the first dose of study.\n\nOther protocol defined inclusion/exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT03981094', 'briefTitle': 'A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM027-041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986278', 'interventionNames': ['Drug: BMS-986278']}, {'type': 'EXPERIMENTAL', 'label': 'Pirfenidone', 'interventionNames': ['Drug: Pirfenidone']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986278 + Pirfenidone', 'interventionNames': ['Drug: BMS-986278', 'Drug: Pirfenidone']}], 'interventions': [{'name': 'BMS-986278', 'type': 'DRUG', 'description': 'suspension', 'armGroupLabels': ['BMS-986278', 'BMS-986278 + Pirfenidone']}, {'name': 'Pirfenidone', 'type': 'DRUG', 'description': 'capsule', 'armGroupLabels': ['BMS-986278 + Pirfenidone', 'Pirfenidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'PRA Health Sciences - Salt Lake', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}