Aficamten administered as single doses of ≤50 mg or daily doses of ≤10 mg for 14 or 17 days was safe and well tolerated in healthy adults, with adverse events similar to placebo.
RCT
double-blind
randomized
Is the cardiac myosin inhibitor aficamten safe, well-tolerated, and pharmacokinetically predictable in healthy adults?
Phase 1 data demonstrates that the cardiac myosin inhibitor aficamten is safe and well-tolerated in healthy adults, supporting its further clinical development.
This phase 1, randomized, double-blind, placebo-controlled study of aficamten (formerly CK-3773274) in healthy adults identified a pharmacologically active range of doses and exposures. At doses that were pharmacologically active (single doses of ≤50 mg or daily dosing of ≤10 mg for 14 or 17 days), aficamten appeared to be safe and well tolerated. Adverse events were generally mild and no more frequent than with placebo. Pharmacokinetic assessments showed dose proportionality over the range of single doses administered, and pharmacokinetics were not affected by administration with food or in otherwise healthy individuals with a cytochrome P450 2D6 poor metabolizer phenotype. (A Single and Multiple Ascending Dose Study of CK-3773274 in Health Adult Subjects; NCT03767855)
Malik et al. (Mon,) conducted a rct in Healthy participants. Aficamten vs. Placebo was evaluated. Aficamten administered as single doses of ≤50 mg or daily doses of ≤10 mg for 14 or 17 days was safe and well tolerated in healthy adults, with adverse events similar to placebo.