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

• DOI: 10.1016/j.jacbts.2022.04.008
• Publication Date: 2022-08-10T22:42:09Z
• Authors: Fady I. Malik; Laura A. Robertson; Danielle R. Armas; Edward P. Robbie; Anna Osmukhina; Donghong Xu; Hanbin Li; Scott D. Solomon
• Keywords: 03 medical and health sciences; 0302 clinical medicine; Original Research - Clinical; 3. Good health

This phase 1, randomized, double-blind, placebo-controlled study of aficamten (formerly CK-3773274) in healthy adults identified a pharmacologically active range doses and exposures. At that were (single ≤50 mg or daily dosing ≤10 for 14 17 days), appeared to be safe well tolerated. Adverse events generally mild no more frequent than with placebo. Pharmacokinetic assessments showed dose proportionality over the single administered, pharmacokinetics not affected by administration food otherwise individuals cytochrome P450 2D6 poor metabolizer phenotype. (A Single Multiple Ascending Dose Study CK-3773274 Health Adult Subjects; NCT03767855)