A Randomized Thorough QT Trial Using Concentration-QT Analysis to Evaluate the Effects of Centanafadine on Cardiac Repolarization.

ABSTRACT: Centanafadine is a norepinephrine/dopamine/serotonin reuptake inhibitor in development for treatment of attention-deficit/hyperactivity disorder. This double-blind, placebo- and moxifloxacin-controlled, 3-period crossover trial evaluated the effects of centanafadine (EB-1020) and its metabolite (EB-10601) on cardiac repolarization in 30 healthy adults (18-65 years). Dosing sequences included centanafadine sustained-release 800 mg (supratherapeutic) total daily dose, placebo, and moxifloxacin 400 mg. Electrocardiogram parameters and heart rate (HR) were assessed. The primary endpoint was placebo-corrected change from baseline QTc (ΔΔQTc), analyzed using concentration-QTc (C-QTc) analysis. The C-QTc slopes for centanafadine (-0.001 ms/[ng/mL]) and EB-10601 (-0.0003 ms/[ng/mL]) were not stati

SUBMITTER: Turkoglu OS 

PROVIDER: S-EPMC12314114 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature