A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
NCT ID: NCT05320094
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2022-04-15
2022-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mavacamten
Mavacamten
Specified dose on specified days
Mavacamten and activated charcoal with sorbitol - Dose A
Mavacamten
Specified dose on specified days
Activated Charcoal with Sorbitol
Specified dose on specified days
Mavacamten and activated charcoal with sorbitol - Dose B
Mavacamten
Specified dose on specified days
Activated Charcoal with Sorbitol
Specified dose on specified days
Interventions
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Mavacamten
Specified dose on specified days
Activated Charcoal with Sorbitol
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments
Exclusion Criteria
* History of sorbitol or fructose intolerance or inability to tolerate activated charcoal
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
18 Years
60 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Dallas, Texas, United States
Countries
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References
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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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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CV027-043
Identifier Type: -
Identifier Source: org_study_id
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