Effect of Tucatinib on Cardiac Repolarization in Healthy Volunteers.

ABSTRACT:

Background and objective

Tucatinib is a selective tyrosine kinase inhibitor of the human epidermal growth factor receptor 2 (HER2) approved to treat metastatic HER2-positive breast and colorectal cancers. The International Council for Harmonisation of Technical Requirements for Human Use (ICH) E14 guideline mandates that new drugs are assessed for potential effects on cardiac repolarization through electrocardiogram (ECG) evaluation in a QT/corrected QT (TQT) study.

Methods

We evaluated the effect of tucatinib on cardiac repolarization in healthy volunteers in a phase I, randomized, partially double-blind, placebo-and positive-controlled three-period crossover study. The primary endpoint was the placebo-corrected change from baseline in QT interval values, corrected for hear

SUBMITTER: Topletz-Erickson AR 

PROVIDER: S-EPMC10676329 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature