A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
NCT ID: NCT05362045
Last Updated: 2022-11-21
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
158 participants
INTERVENTIONAL
2022-05-16
2022-08-19
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- Dose A
Mavacamten
Specified dose on specified days
Mavacamten- Dose B
Mavacamten
Specified dose on specified days
Interventions
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Mavacamten
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments within the normal range at the screening visit and/or on Day -1
Exclusion Criteria
* 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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Clinical pharmacology of Miami
Miami, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
QPS Springfield
Springfield, Missouri, United States
Ppd Phase I Clinic
Austin, Texas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CV027-070
Identifier Type: -
Identifier Source: org_study_id
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