Background: The assessment of QTc changes after the intake of a standardized meal has been proposed as an alternative approach to prove assay sensitivity when the proarrhythimic potential of a drug is to be excluded in either TQT or intensive Phase I QT studies.
Methods: In this article, an analysis of the food effect at baseline across periods in two different studies is presented to support the robustness of the method.
Results: The results show that the time-effect attributed to food is stable over different study periods demonstrating consistency of the physiological response triggered by food.
Conclusions: Stability and reproducibility of the effect is comparable with moxifloxacin.
Keywords: QTc; assay sensitivity; food effect; interval.
© 2016 Wiley Periodicals, Inc.