Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-23 @ 3:25 PM
Study NCT ID:
NCT06433505
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Apparent terminal plasma half-life (T-HALF)', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Total body clearance (CLT)', 'timeFrame': 'Up to Day 15', 'description': 'Part A'}, {'measure': 'Apparent total body clearance (CLT/F)', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Mean residence time (MRT)', 'timeFrame': 'Up to Day 15', 'description': 'Part A'}, {'measure': 'Apparent volume of distribution (Vz)', 'timeFrame': 'Up to Day 15', 'description': 'Part A'}, {'measure': 'Apparent volume of distribution (Vz/F)', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Absolute bioavailability (F)', 'timeFrame': 'Up to Day 15', 'description': 'Part A'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Adverse Events', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Number of participants with Serious Adverse Events', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Number of participants with AEs leading to discontinuation', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Number of participants with Vital sign abnormalities', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to Day 60', 'description': 'Part A and B'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986365', 'Pharmacokinetics', 'Absolute Bioavailability', 'Healthy Male Volunteers', 'CC-94676', 'ADME'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator\n* Participants will require a left ventricular ejection fraction of \\> 50% at screening.\n* Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height \\[m\\])2.\n\nExclusion Criteria:\n\n* Any current or recent significant acute or chronic illness.\n* Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (\\> 450 ms) at screening.\n* Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.\n* History of allergy to BMS-986365 or related compounds.\n\nOther protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06433505', 'briefTitle': 'A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants', 'orgStudyIdInfo': {'id': 'CA071-1005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'interventionNames': ['Drug: BMS-986365', 'Drug: [14C] BMS-986365']}, {'type': 'EXPERIMENTAL', 'label': 'Part B - Arm 1', 'interventionNames': ['Drug: [14C] BMS-986409 + BMS-986410']}, {'type': 'EXPERIMENTAL', 'label': 'Part B - Arm 2', 'interventionNames': ['Drug: [14C] BMS-986410 + BMS-986409']}], 'interventions': [{'name': 'BMS-986365', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A']}, {'name': '[14C] BMS-986365', 'type': 'DRUG', 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Part A']}, {'name': '[14C] BMS-986409 + BMS-986410', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part B - Arm 1']}, {'name': '[14C] BMS-986410 + BMS-986409', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part B - Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}