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

From Hoffman-La Roche Inc, Nutley, New Jersey (Dr Zhang); Hoffman-La Roche AG, Basel, Switzerland (Ms Silkey); and Roche Palo Alto LLC, Palo Alto, California (Ms Schumacher, Ms Wang, Ms Raval, and Dr Caulfield).

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.

Key Words: Baseline-Adjusted • thorough QT/QTc study (TQT study) • moxifloxacin • time-matched baseline • predose baseline

Address for reprints: Xiaoping Zhang, PhD, Department of Clinical Pharmacology, Hoffman-La Roche Inc, 340 Kingsland Street, Nutley, NJ 07110; e-mail: Amy.zhang{at}roche.com.

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