2018
DOI: 10.1111/cts.12594
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Electrocardiographic Effects of a Supratherapeutic Dose of WCK 2349, a Benzoquinolizine Fluoroquinolone

Abstract: 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… Show more

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Cited by 13 publications
(10 citation statements)
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“…The excellent oral bioavailability of levonadifloxacin not affected by food, coupled with favourable pharmacokinetic and pharmacodynamics profile makes it a preferred antibiotic for varied infections including anaerobic infections. Non-clinical and clinical studies have established an excellent safety profile of levonadifloxacin with lack of potential adverse effects, such as phototoxicity, prolongation of QT interval, [19] hepatotoxicity, and nephrotoxicity, thus potentially offering a better option for the treatment of bacterial CABP. Levonadifloxacin could be a preferred antibiotic of choice for empirical therapy, which enables the clinician for easy switch-over from injectable to oral therapy.…”
Section: Discussionmentioning
confidence: 99%
“…The excellent oral bioavailability of levonadifloxacin not affected by food, coupled with favourable pharmacokinetic and pharmacodynamics profile makes it a preferred antibiotic for varied infections including anaerobic infections. Non-clinical and clinical studies have established an excellent safety profile of levonadifloxacin with lack of potential adverse effects, such as phototoxicity, prolongation of QT interval, [19] hepatotoxicity, and nephrotoxicity, thus potentially offering a better option for the treatment of bacterial CABP. Levonadifloxacin could be a preferred antibiotic of choice for empirical therapy, which enables the clinician for easy switch-over from injectable to oral therapy.…”
Section: Discussionmentioning
confidence: 99%
“…WCK 2349 had no effect on baseline and placebo-corrected QTcF (QT interval adjusted for heart rate using the Fridericia method), QRS, or PR interval. Except for a possibly transient elevation in HR, which appears to be clinically negligible, a supratherapeutic dose of WCK 2349 is not likely to elicit clinically significant ECG effects and thus can provide a viable alternative to QT prolonging antibiotics ( NCT02217930 ) [ 66 ].…”
Section: Meeting the Unmet Need With Levonadifloxacin IV And Oralmentioning
confidence: 99%
“…46,47 WCK 771 when dosed at 800 mg intravenously and its pro-drug (WCK 2349) dosed at 1000mg orally in clinical trials attained a half-life of 6 h, a concentration that when dosed BID systemically has been effective to treat MRSA infections. 48,49…”
Section: Treatment Of the Futurementioning
confidence: 99%