Key result
Moxifloxacin increased the placebo-adjusted change from baseline in the QTc interval by an estimated 13.4 ms (90% CI 11.3-15.4) at a mean Cmax of 2.95 μg/mL.
Why the study?
Does moxifloxacin induce QTc prolongation detectable by exposure-response modelling in early-phase studies?
Population
46 subjects from a crossover thorough QT/QTc study
Comparison
Moxifloxacin vs Placebo
Design
Other
Authors
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Validates exposure-response modeling for QTc assessment in small early-phase studies; supports its use to estimate drug liability.
RCT (n=46)
Does moxifloxacin induce QTc prolongation detectable by exposure-response modelling in early-phase studies?
Mean Difference: 13.4 (95% CI 11.3–15.4)
Intensive ECG collection and exposure-response modelling in early-phase studies with small sample sizes can effectively estimate QT liability.
Panicker et al. (2016) reported an RCT. Moxifloxacin vs. Placebo was evaluated on placebo-adjusted change from baseline in the QTc interval (ΔΔQTcF) (MD 13.4 ms, 95% CI 11.3-15.4). Moxifloxacin increased the placebo-adjusted change from baseline in the QTc interval by an estimated 13.4 ms (90% CI 11.3-15.4) at a mean Cmax of 2.95 μg/mL.
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