Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-22 @ 12:52 PM
Study NCT ID:
NCT06577259
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2024-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 105 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]', 'timeFrame': 'Up to 105 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]', 'timeFrame': 'Up to 105 days'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)]', 'timeFrame': 'Up to 105 days'}, {'measure': 'Time of maximum observed concentration [Tmax]', 'timeFrame': 'Up to 105 days'}, {'measure': 'Apparent terminal half-life [T-HALF]', 'timeFrame': 'Up to 105 days'}, {'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'Up to approximately 5 months'}, {'measure': 'Incidence of serious adverse events (SAEs)', 'timeFrame': 'Up to approximately 5 months'}, {'measure': 'Incidence of participants with vital sign abnormalities', 'timeFrame': 'Up to 105 days'}, {'measure': 'Incidence of participants with physical examinations abnormalities', 'timeFrame': 'Up to 105 days'}, {'measure': 'Incidence of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 105 days'}, {'measure': 'Incidence of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 105 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986435', 'MYK-224', 'Healthy participants', 'Single-dose'], '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.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m\\^2, inclusive.\n* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.\n* Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.\n\nExclusion Criteria:\n\n* Any acute or chronic medical illness.\n* History of heart disease.\n* Prior exposure to BMS-986435.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06577259', 'briefTitle': 'Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Open-label, Single-site, Randomized, Single-dose, Three-way, Crossover Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations in Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'CV029-1018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A: BMS-986435 Reference Dose 1', 'interventionNames': ['Drug: BMS-986435']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: BMS-986435 Test Dose 1', 'interventionNames': ['Drug: BMS-986435']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C: BMS-986435 Test Dose 2', 'interventionNames': ['Drug: BMS-986435']}], 'interventions': [{'name': 'BMS-986435', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Treatment A: BMS-986435 Reference Dose 1', 'Treatment B: BMS-986435 Test Dose 1', 'Treatment C: BMS-986435 Test Dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}