A Phase 1 Dose-Escalation Study of the Cardiac Myosin Inhibitor Aficamten in Healthy Participants

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. (C) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

Automated summary

This phase 1 study investigated the pharmacologically active range, safety, and tolerability of aficamten in healthy adults. The results showed that aficamten exhibited a safe profile and was well tolerated at pharmacologically active doses. The pharmacokinetics of aficamten were not affected by food intake or the presence of a specific genetic phenotype.