Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
- Registration Number
- NCT06122779
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 208
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BMS-986435 BMS-986435 -
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (TEAEs) Up to approximately 24 weeks Incidence of serious adverse events (SAEs) Up to approximately 24 weeks Incidence of AEs leading to treatment discontinuation Up to approximately 20 weeks
- Secondary Outcome Measures
Name Time Method Summary of plasma concentrations of MYK-224 Up to approximately 20 weeks
Trial Locations
- Locations (116)
Centro de Especialidades Médicas CEMEDIC
🇦🇷Buenos Aires, Argentina
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Colorado Heart and Vascular - Lakewood
🇺🇸Lakewood, Colorado, United States
Ascension St. Vincent's Riverside Hospital
🇺🇸Jacksonville, Florida, United States
Local Institution - 0003
🇺🇸Miami, Florida, United States
Local Institution - 0099
🇺🇸Miami, Florida, United States
Local Institution - 0014
🇺🇸Atlanta, Georgia, United States
Local Institution - 0048
🇺🇸Atlanta, Georgia, United States
Bluhm Cardiovascular Institute of Northwestern
🇺🇸Chicago, Illinois, United States
Chicago Medical Research, LLC
🇺🇸Hazel Crest, Illinois, United States
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