This is a single-center, 2-part (Part A and Part B) study in healthy participants. Part A (Dose Finding) is an open-label, SAD study to identify the dose for Part B. Part B (TQT Study) is a randomized, double-blind (with respect to aficamten and matching placebo), positive- and placebo-controlled, single-dose, 3-way crossover study to evaluate the effect of aficamten administration on QT/QTc interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
44
Celerion, Inc 2420
Tempe, Arizona, United States
Part A: To determine the dose for Part B
To determine the dose for Part B based on Part A PK and safety data.
Time frame: Baseline to End of Study, up to 8 weeks
Part B: placebo-corrected dQTcF for aficamten
To evaluate the effect of a single oral dose of aficamten on the QTc interval in healthy participants.
Time frame: Baseline to End of Study, up to 14.5 weeks
Part B: placebo-corrected dQTcF for moxifloxacin
To demonstrate assay sensitivity of the study to detect a small QTc effect using moxifloxacin as a positive control in healthy participants.
Time frame: Baseline to End of Study, up to 14.5 weeks
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