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Period correction of the QTc of moxifloxacin with multiple predose baseline ECGs is the least variable of 4 methods tested.

Author(s): Zhang X, Silkey M, Schumacher M, Wang L, Raval H, Caulfield JP

Affiliation(s): Department of Clinical Pharmacology, Hoffman-La Roche Inc, Nutley, NJ 07110, USA. Amy.zhang@roche.com

Publication date & source: 2009-05, J Clin Pharmacol., 49(5):534-9. Epub 2009 Mar 13.

Publication type: Comparative Study; Randomized Controlled Trial

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.

Page last updated: 2009-10-20

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