This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy (nHCM).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
University of California, San Francisco
San Francisco, California, United States
Incidence of treatment-emergent adverse events
Time frame: From screening through study completion (Part A: Up to 38 days; Part B and C: Up to 73 days; Part D: Up to 18 months)
Change from baseline in left ventricular outflow tract (LVOT) gradient
Resting and post-Valsalva LVOT gradient by echocardiography
Time frame: From baseline through study completion (Part A: Up to 10 days; Part B: Up to 38 days; Part D: Up to 18 months)
Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax)
Time frame: From baseline through study completion (Part A: Up to 10 days)
Change from baseline in cardiac biomarkers
Time frame: From baseline through study completion (Part B and C: Up to 38 days; Part D: Up to 18 months)
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