Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT05320094
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2022-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000881', 'term': 'Anthrax'}], 'ancestors': [{'id': 'D016863', 'term': 'Bacillaceae Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000605992', 'term': 'MYK-461'}, {'id': 'D002606', 'term': 'Charcoal'}, {'id': 'D013012', 'term': 'Sorbitol'}], 'ancestors': [{'id': 'D002244', 'term': 'Carbon'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2022-04-01', 'studyFirstSubmitQcDate': '2022-04-01', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))', 'timeFrame': 'Up to 2 months'}, {'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 2 months'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 1 month'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Number of participants with vital sign abnormalities exceeding predefined thresholds', 'timeFrame': 'Up to 3 months'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 3 Months'}, {'measure': 'Number of participants with physical exam abnormalities', 'timeFrame': 'Up to 3 months'}, {'measure': 'Number of participants with clinical laboratory evaluation abnormalities', 'timeFrame': 'Up to 3 months'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to 1 month'}, {'measure': 'Apparent terminal plasma half-life (T-HALF)', 'timeFrame': 'Up to 2 months'}, {'measure': 'Concentration at 24 hours (C24)', 'timeFrame': 'Up to 1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mavacamten', 'Sorbitol', 'Activated Charcoal'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'references': [{'pmid': '38926266', 'type': 'DERIVED', 'citation': 'Merali S, Chiang M, Sychterz C, Chao L, Simmons T, Xu Y, Zhao A, Attanasio M, Murthy B, Perera V. Effect of Activated Charcoal on Mavacamten Pharmacokinetics in Healthy Participants. Am J Cardiovasc Drugs. 2024 Jul;24(4):569-575. doi: 10.1007/s40256-024-00659-z. Epub 2024 Jun 26.'}], '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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten 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 30 kg/m\\^2, inclusive, at the Screening Visit\n* Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments\n\nExclusion Criteria:\n\n* Current or recent (within 3 months of study intervention administration) gastrointestinal disease\n* History of sorbitol or fructose intolerance or inability to tolerate activated charcoal\n* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05320094', 'briefTitle': 'A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants', 'orgStudyIdInfo': {'id': 'CV027-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mavacamten', 'interventionNames': ['Drug: Mavacamten']}, {'type': 'EXPERIMENTAL', 'label': 'Mavacamten and activated charcoal with sorbitol - Dose A', 'interventionNames': ['Drug: Mavacamten', 'Drug: Activated Charcoal with Sorbitol']}, {'type': 'EXPERIMENTAL', 'label': 'Mavacamten and activated charcoal with sorbitol - Dose B', 'interventionNames': ['Drug: Mavacamten', 'Drug: Activated Charcoal with Sorbitol']}], 'interventions': [{'name': 'Mavacamten', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Mavacamten', 'Mavacamten and activated charcoal with sorbitol - Dose A', 'Mavacamten and activated charcoal with sorbitol - Dose B']}, {'name': 'Activated Charcoal with Sorbitol', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Mavacamten and activated charcoal with sorbitol - Dose A', 'Mavacamten and activated charcoal with sorbitol - Dose B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247-4989', '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'}}}}