Determination of moxifloxacin QTc sensitivity in NHP to support ICH E14/S7B Q&A compliant studies using a parallel ascending or an ascending dose design

SPS 2025 -- Best practices for in vivo QTc assessment includes characterization of study sensitivity, verification of independence of QTc from heart rate, demonstration of test facility sensitivity and pharmacological translation to human using a positive control. Industry efforts have centred on assessing QTc sensitivity using best practice cross-over designs with animals serving as their own controls. However, for long half-life compounds, this approach is unsuitable due to potential carryover effects between dosing sessions. The objective of this study was to determine QTc sensitivity with moxifloxacin in telemetry implanted nonhuman primate (NHP) to support ICH E14/S7B Q&A compliant cardiovascular studies using a parallel ascending dose (PAD; N=12) or an ascending dose (AD; N=6) design.