Levadex: QT/QTc study data
A double-blind, placebo-controlled, 3-way crossover QT interval study in 54 healthy volunteers showed that a supra-therapeutic dose (about 3 times the anticipated commercial dose) of Levadex did not cause an increase in QTc intervals. Specifically, the largest mean difference from placebo in QTc interval for Levadex was 0.08 milliseconds, with the largest one-sided 95% upper confidence interval bound at 2.24 milliseconds. Map said the threshold of regulatory concern is when the upper bound exceeds 10 milliseconds. Additionally, the proportion of subjects with individual QTc intervals >450 milliseconds and increases in QTc from baseline of >30 milliseconds were similar to placebo. The positive control moxifloxacin produced QT prolongation consistent with previous QT trials. The QT interval study was conducted in support of an NDA submission planned for 1H11 for Levadex to treat acute migraine. ...