Vol.55 No.S-1 October 2007
Relationship between oral administration of garenoxacin and QT interval
Fourth Department of Internal Medicine, Mizonokuchi Hospital, Teikyo University School of Medicine
Abstract
The effect of garenoxacin mesilate hydrate(GRNX), a novel quinolone antimicrobial, on QT interval was investigated. Electrocardiogram data from 66 healthy volunteers was analyzed in the clinical pharmacology study, and 504 patients who received 400 mg/dose/day in phase III clinical trials on infected patients.
At around Tmax (two hours after administration) of the single dose study, in the subject group who received 600 mg administration, the mean QTc was 365.8±26.9 msec, and the mean ⊿QTc was -1.8±25.4 msec, and did not have the tendency to prolong QTc.
The mean ⊿QTc of phase III clinical studies were -10.5±27.0 msec at three days after administration, and -9.0±27.8 msec at nine days after administration, and there was no tendency of prolongation.
In an analysis by category, there were three of 504 patients in phase III clinical trials who had QTc exceeding 450 msec (470 msec: females) and ⊿QTc exceeded 60 msec, but these QTc and ⊿QTc were due to a clinical background.
In an investigation on the relationship between ⊿QTc and the plasma concentration of the drug, no correlation was observed. No significant changes in the electrocardiogram wave pattern by this drug or adverse events related to QTc prolongation were observed. No correlation was observed between QTc or ⊿QTc, and age or weight distribution of patients.
From these observations, we conclude that GRNX has no appreciable effect on QTc intervals.
Key word
garenoxacin, des-fluoro(6)-quinolone, electrocardiogram, QT
Received
May 18, 2007
Accepted
July 26, 2007
Jpn. J. Chemother. 55 (S-1): 214-221, 2007
