Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-01 @ 1:52 AM
Study NCT ID:
NCT05719805
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D000092242', 'term': 'Ventricular Outflow Obstruction, Left'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000605992', 'term': 'MYK-461'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-01-31', 'lastUpdatePostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Predose and post-dose up to Day 80'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])', 'timeFrame': 'Predose and post-dose up to Day 80'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])', 'timeFrame': 'Predose and post-dose up to Day 80'}], 'secondaryOutcomes': [{'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Predose and post-dose up to Day 80'}, {'measure': 'Terminal Half-life (T-Half)', 'timeFrame': 'Predose and post-dose up to Day 80'}, {'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to Day 80'}, {'measure': 'Number of Participants with Serious AEs (SAEs)', 'timeFrame': 'Up to Day 80'}, {'measure': 'Number of Participants with Vital Sign Abnormalities', 'timeFrame': 'Up to Day 80'}, {'measure': 'Number of Participants with Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Up to Day 80'}, {'measure': 'Number of Participants with Physical Examination Abnormalities', 'timeFrame': 'Up to Day 80'}, {'measure': 'Number of Participants with Clinical Laboratory Abnormalities', 'timeFrame': 'Up to Day 80'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertrophic cardiomyopathy (HCM)', 'Left ventricular (LV) hypertrophy', 'Bioequivalence', 'Left Ventricular Outflow Tract Obstruction', 'Heart diseases', 'Cardiovascular diseases'], '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'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index between 18 and 32 kg/m\\^2, inclusive, at the screening visit.\n* Healthy, as determined by physical examination, vital signs, 12-lead ECGs, and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1. Participants with values outside of the normal range may be included if the values are not considered, by the investigator, to be clinically significant unless such values are explicitly excluded.\n* Cytochrome P450 (CYP2C19) normal (\\*1/\\*1), rapid (\\*1/\\*17), or ultra-rapid (\\*17/\\*17) metabolizer, as determined by genotyping during screening.\n\nExclusion Criteria:\n\n* Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, LV systolic dysfunction, coronary heart disease; current, history, or family history of HCM; or evidence of prior myocardial infarction based on ECGs.\n* Current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.\n* Any gastrointestinal surgery (other than appendectomy) that, in the opinion of the investigator, could impact the absorption of study intervention.\n\nNote: Other protocol-defined inclusion/exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT05719805', 'briefTitle': 'A Study to Evaluate the Effects of Mavacamten in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, 2-way Crossover Study to Establish Bioequivalence of 1 × 15-mg Mavacamten Capsule to 3 × 5-mg Mavacamten Capsules in Healthy Participants', 'orgStudyIdInfo': {'id': 'CV027-1090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mavacamten Dose 1', 'interventionNames': ['Drug: Mavacamten']}, {'type': 'EXPERIMENTAL', 'label': 'Mavacamten Dose 2', 'interventionNames': ['Drug: Mavacamten']}], 'interventions': [{'name': 'Mavacamten', 'type': 'DRUG', 'otherNames': ['MYK-461'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Mavacamten Dose 1', 'Mavacamten Dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Local Institution - 0002', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], '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. Additional information regarding Bristol Myers 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'}}}}