Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-29 @ 7:19 PM
Study NCT ID:
NCT04065932
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2019-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}, {'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2019-08-21', 'studyFirstSubmitQcDate': '2019-08-21', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) for BMS-986165', 'timeFrame': 'Day 1 of treatment'}, {'measure': 'Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165', 'timeFrame': 'Day 1 of treatment'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165', 'timeFrame': 'Day 1 of treatment'}], 'secondaryOutcomes': [{'measure': 'Time to maximum observed plasma concentration-(Tmax) for BMS -986165', 'timeFrame': 'Day 1 of treatment'}, {'measure': 'Apparent plasma elimination half-life- (T-HALF) for BMS-986165', 'timeFrame': 'Day 1 of treatment'}, {'measure': 'Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165', 'timeFrame': 'Day 1 of treatment'}, {'measure': 'Apparent clearance -(CL/F) for BMS-986165', 'timeFrame': 'Day 1 of treatment'}, {'measure': 'Concentration observed at 24 hours-(C24) for BMS-986165', 'timeFrame': 'Day 1 of treatment'}, {'measure': 'Concentration observed at 12 hours-(C12) for BMS-986165', 'timeFrame': 'Day 1 of treatment'}, {'measure': "Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy.", 'timeFrame': 'Approximately 16 weeks'}, {'measure': 'Incidence of serious adverse events (SAE) leading to discontinuation of study therapy.', 'timeFrame': 'Approximately 16 weeks.'}, {'measure': 'Incidence of adverse events (AEs) leading to discontinuation of study therapy.', 'timeFrame': 'Approximately 16 weeks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus']}, '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': 'A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets'}, '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* Patients must be willing and able to complete all study-specific procedures and visits\n* Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations\n* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening\n* Normal renal function at screening\n\nExclusion Criteria:\n\n* History or presence of chronic bacterial, viral infection, or autoimmune disorder\n* Active TB requiring treatment or documented latent TB within the previous 3 years\n* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption\n* WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.'}, 'identificationModule': {'nctId': 'NCT04065932', 'briefTitle': 'A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered as Various Solid Dispersion Tablet Formulations in Healthy Subjects', 'orgStudyIdInfo': {'id': 'IM011-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-985165-01 prototype formulation 1', 'interventionNames': ['Drug: BMS-986165-01']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986165 Tablet', 'interventionNames': ['Drug: BMS-986165 Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-985165-01 prototype formulation 2', 'interventionNames': ['Drug: BMS-986165-01']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-985165-01 prototype formulation 3', 'interventionNames': ['Drug: BMS-986165-01']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-985165-01 prototype formulation 3 or 4', 'interventionNames': ['Drug: BMS-986165-01', 'Drug: Famotidine']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-985165-01 prototype formulation 3, 4 or 5', 'interventionNames': ['Drug: BMS-986165-01', 'Drug: Famotidine']}], 'interventions': [{'name': 'BMS-986165-01', 'type': 'DRUG', 'description': 'Participants will receive BMS- 986165 -01 in prototype formulation', 'armGroupLabels': ['BMS-985165-01 prototype formulation 1', 'BMS-985165-01 prototype formulation 2', 'BMS-985165-01 prototype formulation 3', 'BMS-985165-01 prototype formulation 3 or 4', 'BMS-985165-01 prototype formulation 3, 4 or 5']}, {'name': 'BMS-986165 Tablet', 'type': 'DRUG', 'description': 'Participants will receive BMS-986165 in tablet form.', 'armGroupLabels': ['BMS-986165 Tablet']}, {'name': 'Famotidine', 'type': 'DRUG', 'description': 'Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine', 'armGroupLabels': ['BMS-985165-01 prototype formulation 3 or 4', 'BMS-985165-01 prototype formulation 3, 4 or 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Sciences', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}