Period Correction of the QTc of Moxifloxacin With Multiple Predose Baseline ECGs Is the Least Variable of 4 Methods Tested.

Autor: Xiaoping Zhang, Silkey, Mariabeth, Schumacher, Marta, Lei Wang, Raval, Hiral, Caulfield, John P.
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Zdroj: Journal of Clinical Pharmacology; May2009, Vol. 49 Issue 5, p534-539, 6p, 1 Chart, 2 Graphs
Abstrakt: This study compares 4 baseline correction methods on the effect of moxifloxacin on the QT/QTc interval: (1) day -1 time-matched baseline electrocardiograms (ECGs), (2) 3 triplicate predose ECGs, (3) 1 triplicate predose ECG, and (4) no baseline correction. Forty-four healthy subjects receive a single dose of moxifloxacin (400 mg), placebo, and 2 doses of an investigational agent in a 4-period crossover fashion. For all 4 methods, the largest mean difference from placebo in the moxifloxacin study-specific QTc is 11.97 to 13.23 ms and occurs at 3 to 4 hours postdose; the lower 90% confidence interval is greater than 5 ms from 2 to 8 hours. The average standard error of the mean is 1.36 ms for 3 triplicate predose ECGs, 1.40 ms for 1 triplicate predose ECG, 1.60 ms for day -1 time-matched baseline ECGs, and 1.65 ms for no baseline correction. Predose baseline methods (3 or 1 triplicate ECGs) are superior to the day -1 time-matched baseline correction or without baseline correction. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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