Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-10 @ 3:35 PM
Study NCT ID:
NCT03930602
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2019-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}, {'id': 'D016666', 'term': 'Fluvoxamine'}], 'ancestors': [{'id': 'D010091', 'term': 'Oximes'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-09', 'studyFirstSubmitDate': '2019-04-26', 'studyFirstSubmitQcDate': '2019-04-26', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-986165', 'timeFrame': '10 days'}, {'measure': 'AUC(0-T) of BMS-986165', 'timeFrame': '10 days'}, {'measure': 'AUC(INF) of BMS-986165', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Fluvoxamine steady-state plasma concentrations', 'timeFrame': '10 days'}, {'measure': 'Percentage of participants with Adverse events (AEs)', 'timeFrame': 'From screening up to end of drug treatment (Day 13)'}, {'measure': 'Percentage of participants with Serious Adverse events (SAEs) and Death', 'timeFrame': 'From screening up to end of drug treatment (Day 13)'}, {'measure': 'Percentage of participants with Adverse events (AEs) leading to discontinutation', 'timeFrame': 'From screening up to end of drug treatment (Day 13)'}, {'measure': 'Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs', 'timeFrame': 'From screening up to end of drug treatment (Day 13)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, '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/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.\n* Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.\n* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \\> 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,\n* Any major surgery within 4 weeks of study drug administration\n* Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.'}, 'identificationModule': {'nctId': 'NCT03930602', 'briefTitle': 'Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Inhibition on the Pharmacokinetics of BMS-986165 in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM011-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986165+Fluvoxamine', 'interventionNames': ['Drug: BMS-986165', 'Drug: Fluvoxamine']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986165 only', 'interventionNames': ['Drug: BMS-986165']}, {'type': 'EXPERIMENTAL', 'label': 'Fluvoxamine only', 'interventionNames': ['Drug: Fluvoxamine']}], 'interventions': [{'name': 'BMS-986165', 'type': 'DRUG', 'description': 'Participants will receive BMS-986165.', 'armGroupLabels': ['BMS-986165 only', 'BMS-986165+Fluvoxamine']}, {'name': 'Fluvoxamine', 'type': 'DRUG', 'description': 'Participants will receive fluvoxamine.', 'armGroupLabels': ['BMS-986165+Fluvoxamine', 'Fluvoxamine only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'ICON Plc (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'}}}}