Active Ingredient: MOMELOTINIB
In a randomized, partially blinded, placebo-controlled, crossover Thorough QT (TQT) study of 48 healthy adults, therapeutic (200 mg) and supratherapeutic (800 mg) oral doses were evaluated alongside moxifloxacin (400 mg) as a positive control. For both momelotinib doses, the upper bounds of the 2-sided 90% confidence intervals for the mean difference from placebo (ΔΔQTcF) were strictly below the 10-ms clinical threshold at all time points. Pharmacokinetic and concentration-effect modeling revealed no positive relationship between plasma levels of momelotinib (or its active metabolite M21) and the QTc interval. The drug demonstrated an acceptable cardiac safety profile, with no clinically significant effects on repolarization.
https://doi.org/10.1002/cpdd.1509