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A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

Launched by BRISTOL-MYERS SQUIBB · Dec 13, 2022

Trial Information

Current as of January 13, 2025

Completed

Keywords

Healthy Participants Mavacamten Bioequivalence

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Body mass index between 18 and 32 kilograms/meter squared (kg/m\^2) inclusive, at the screening visit.
  • Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1.
  • Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.
  • Exclusion Criteria:
  • Any significant acute or chronic medical illness.
  • Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.
  • CYP2C19 poor (\*2/\*2, \*3/\*3, or \*2/\*3) or intermediate (\*1/\*2, \*1/\*3, \*2/\*17) metabolizer, as determined by genotyping during screening.
  • Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.
  • Note: Other protocol-defined inclusion/exclusion criteria apply.

Trial Officials

Bristol-Myers Squibb

Study Director

Bristol-Myers Squibb

About Bristol Myers Squibb

Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.

Locations

Anaheim, California, United States

Miami, Florida, United States

Springfield, Missouri, United States

Anaheim, California, United States

Miami, Florida, United States

Springfield, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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