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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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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