Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-25 @ 3:08 PM
Study NCT ID:
NCT04113668
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2019-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}, {'id': 'D004061', 'term': 'Diflunisal'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor', 'timeFrame': 'Up to 14 days'}, {'measure': 'Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor', 'timeFrame': 'up to 14 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor', 'timeFrame': 'up to 14 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'up to 48 days'}, {'measure': 'Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'up to 48 days'}, {'measure': 'Physical Examination of weight', 'timeFrame': 'up to 48 days'}, {'measure': 'Number of changes in blood pressure', 'timeFrame': 'up to 20 days'}, {'measure': 'Number of changes in body temperature', 'timeFrame': 'up to 20 days'}, {'measure': 'Number of changes in respiratory rate', 'timeFrame': 'up to 20 days'}, {'measure': 'Number of clinical significant changes in lab assessment of blood serum', 'timeFrame': 'up to 48 days'}, {'measure': 'Number of Clinically significant changes in assessment of blood', 'timeFrame': 'up to 20 days'}, {'measure': 'Number of Clinically significant changes in lab assessment of urine', 'timeFrame': 'up to 20 days'}]}, 'oversightModule': {'oversightHasDmc': False, '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': 'BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the effect of blocking one pathway in the drug levels of BMS-986165 in health subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 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* Women and men must agree to follow instructions for methods of contraception.\n* Participants must be willing and able to complete all study-specific procedures and visits.\n* A healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.\n* WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.\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, including a history of active liver disease\n* History of biliary disorders, including Gilbert's syndrome or Dubin- Johnson disease, in addition to, current or recent gastrointestinal disease that could impact the absorption of study drug.\n* Participants using electronic cigarettes or nicotine-containing products who have stopped smoking less than 6 months prior to dosing on Day 1.\n* Consumption of chargrilled meat, quinine, or any nutrient known to modulate CYP enzyme activity within 14 days prior to first administration of study treatment.\n* History of any significant drug allergy\n\nOther inclusion/exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04113668', 'briefTitle': 'The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'AN OPEN-LABEL, SINGLE-SEQUENCE, CROSSOVER STUDY TO INVESTIGATE THE EFFECTS OF UGT1A9 INHIBITOR DIFLUNISAL, AT STEADY-STATE, ON PHARMACOKINETICS OF A SINGLE DOSE OF BMS-986165 IN HEALTHY MALE AND FEMALE VOLUNTEERS', 'orgStudyIdInfo': {'id': 'IM011-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Single Dose (BMS-986165)', 'interventionNames': ['Drug: BMS-986165']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B:Diflunisal and Single Dose (BMS-986165)', 'interventionNames': ['Drug: BMS-986165', 'Drug: diflunisal']}], 'interventions': [{'name': 'BMS-986165', 'type': 'DRUG', 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Arm A: Single Dose (BMS-986165)', 'Arm B:Diflunisal and Single Dose (BMS-986165)']}, {'name': 'diflunisal', 'type': 'DRUG', 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Arm B:Diflunisal and Single Dose (BMS-986165)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'PRA Health Sciences - Lenexa', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}