Assessment of QT_c‐prolonging potential of BX471 in healthy volunteers. A ‘thorough QT_c study’ following ICH E14 using various QT correction methods

Abstract

BX471 does not cause meaningful QT(c) prolongation. Three QT correction methods may be sufficient in future studies: Bazett's (required by regulatory authorities), Fridericia's (as the most reliable fixed formula) and a regression-based correction (individually or population-based), each performed per ECG (i.e. applied to the means of several beats of one ECG recording).