Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-01-01 @ 11:38 PM
Study NCT ID:
NCT03563950
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2018-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2018-06-11', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-986224', 'timeFrame': '5 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224', 'timeFrame': '5 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'Biomarker plasma concentrations of BMS-986224', 'timeFrame': '5 days'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of BMS-986224', 'timeFrame': '5 days'}, {'measure': 'Terminal elimination half-life (T-HALF) of BMS-986224', 'timeFrame': '5 days'}, {'measure': 'Metabolite of BMS-986224 Cmax', 'timeFrame': '5 days'}, {'measure': 'Metabolite of BMS-986224 AUC(0-T)', 'timeFrame': '5 days'}, {'measure': 'Metabolite of BMS-986224 AUC(INF)', 'timeFrame': '5 days'}, {'measure': 'Incidence of nonserious adverse events (AE)', 'timeFrame': '17 days'}, {'measure': 'Incidence of serious adverse events (SAE)', 'timeFrame': '30 days'}, {'measure': 'Incidence of AEs leading to discontinuation', 'timeFrame': '17 days'}, {'measure': 'Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests', 'timeFrame': '18 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, '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 purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n* Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening\n\nExclusion Criteria:\n\n* Women of childbearing potential\n* Any significant acute or chronic medical illness\n* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy\n\nOther protocol defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03563950', 'briefTitle': 'An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CV016-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rifampin + BMS-986224', 'description': 'Oral administration', 'interventionNames': ['Drug: Rifampin', 'Drug: BMS-986224']}], 'interventions': [{'name': 'Rifampin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Rifampin + BMS-986224']}, {'name': 'BMS-986224', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Rifampin + BMS-986224']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'PRA Health Sciences', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}