Clinical Evaluation of the Effect of Aficamten on QT/QTc Interval in Healthy Participants.

ABSTRACT: Aficamten is a next-in-class, small-molecule, cardiac myosin inhibitor in development for treating hypertrophic cardiomyopathy (HCM). This 2-part study evaluated aficamten's impact on QTc interval in healthy participants. Part A (n = 10) was an open-label study to find the appropriate dose for thorough QT (TQT) evaluation in Part B. Part B (n = 34) was a double-blind, 3-way crossover TQT study conducted as per ICH E14 guidance using negative (placebo) and positive (moxifloxacin) controls. A single 50 mg aficamten dose achieved exposures (C_max range: 124-1660 ng/mL) comparable to the highest clinical dose (20 mg QD) in obstructive HCM patients (NCT05186818; [C_max range: 131-1230 ng/mL]) and was chosen for TQT evaluation. Using concentration-QT (C-QT) modeling, the plac

SUBMITTER: Maharao N 

PROVIDER: S-EPMC11979292 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature