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The purpose of this study was to measure the electrocardiographic (ECG) effects of  WCK  2349 (the L‐alanine ester prodrug of levonadifloxacin) at a supratherapeutic oral dose of 2,600 mg. A total of 48 healthy volunteers were randomized to treatment with placebo,  WCK  2349, or oral moxifloxacin, 400 mg, in a crossover‐designed thorough  QT  study. A supratherapeutic mean maximum levonadifloxacin concentration ( C  max ) of 43.3 μg/mL was achieved at 3.1 hours. A therapeutic dose of 1,000 mg b.i.d. in a previous study in patients resulted in a  C  max  of 17.8 μg/mL.  WCK  2349 exerted no significant effect on baseline‐ and placebo‐corrected  QT cF (QT interval corrected for heart rate (HR) by the Fridericia formula),  QRS,  or  PR  interval.  HR  was transiently accelerated by a maximum of 14.4 (95% confidence interval, 11.80–16.92) beats per minute (bpm) at 3 hours. Concentration–effect modeling predicted a mean increase of 8.0 bpm at  C  max  at the standard therapeutic dose. A therapeutic dose of 1,000 mg b.i.d. of  WCK  2349 is not expected to cause clinically significant ECG effects, except for a possible transient increase in  HR , which seems to be clinically insignificant.

Electrocardiographic Effects of a Supratherapeutic Dose of WCK 2349, a Benzoquinolizine Fluoroquinolone