Active Ingredient: CEFIDEROCOL
In a Phase I, randomized, 4-period crossover Thorough QT (TQT) study in healthy adults, single therapeutic (2 g) and supratherapeutic (4 g) doses were administered via a 3-hour intravenous infusion. Moxifloxacin (400 mg) served as a positive control. Continuous cardiac monitoring showed that all time-matched placebo- and baseline-adjusted QTc intervals (ΔΔQTcF) were <5 ms, with the upper bound of the 90% confidence interval remaining strictly below the 10-ms clinical threshold at all timepoints. Concentration-effect modeling demonstrated a slightly negative slope, predicting a modest decrease in ΔΔQTcF at maximum plasma concentration (Cmax).
https://doi.org/10.1016/j.clinthera.2019.07.006