Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT05304533
Status:
COMPLETED
Last Update Posted:
2023-01-13
First Post:
2022-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D014700', 'term': 'Verapamil'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 36 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])', 'timeFrame': 'Up to 36 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])', 'timeFrame': 'Up to 36 days'}], 'secondaryOutcomes': [{'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to 36 days'}, {'measure': 'Apparent terminal plasma half-life (T-HALF)', 'timeFrame': 'Up to 36 days'}, {'measure': 'Apparent total body clearance (CLT/F)', 'timeFrame': 'Up to 36 days'}, {'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 52 days'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 52 days'}, {'measure': 'Number of participants with adverse events leading to discontinuation', 'timeFrame': 'Up to 52 days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 52 days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 52 days'}, {'measure': 'Measurement of left ventricular ejection fraction (LVEF)', 'timeFrame': 'Up to 52 days'}, {'measure': 'Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)', 'timeFrame': 'Up to 52 days'}, {'measure': 'Measurement of left ventricular fractional shortening (LVFS)', 'timeFrame': 'Up to 52 days'}, {'measure': 'Measurement of left ventricular global longitudinal strain (LV GLS)', 'timeFrame': 'Up to 52 days'}, {'measure': 'Measurement of left ventricle stroke volume (LVSV)', 'timeFrame': 'Up to 52 days'}, {'measure': 'Number of participants with physical exam abnormalities', 'timeFrame': 'Up to 52 days'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 52 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MYK-224', 'Itraconazole', 'Verapamil'], '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/us/en/home.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index between 18 and 30 kg/m\\^2, inclusive\n* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments\n* Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment\n* Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing\n\nExclusion Criteria:\n\n* Any acute or chronic medical illness\n* History of dizziness and/or recurrent headaches\n* History of heart disease\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05304533', 'briefTitle': 'A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label, 3-Arm, Parallel Design Pharmacokinetic Interaction Study Between MYK-224 and Cytochrome P450 3A4 Inhibitors Itraconazole and Verapamil in Healthy Participants', 'orgStudyIdInfo': {'id': 'CV029-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: MYK-224', 'interventionNames': ['Drug: MYK-224']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: MYK-224 + Itraconazole', 'interventionNames': ['Drug: MYK-224', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: MYK-224 + Verapamil', 'interventionNames': ['Drug: MYK-224', 'Drug: Verapamil']}], 'interventions': [{'name': 'MYK-224', 'type': 'DRUG', 'otherNames': ['BMS-986435'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm 1: MYK-224', 'Arm 2: MYK-224 + Itraconazole', 'Arm 3: MYK-224 + Verapamil']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm 2: MYK-224 + Itraconazole']}, {'name': 'Verapamil', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm 3: MYK-224 + Verapamil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}