Healthy Adult Male and Female Volunteers Clinical Trial
Official title:
Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers
Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers
This single-center Phase I study will consist of 2 parts, a Pilot Part and a Core Part.
The Pilot Part of the study will be an open-label, non-randomized, single-treatment design
in 10 healthy male and female subjects to determine if an infusion regimen of a 6-h
continuous IV infusion of exenatide will lead to a mean plasma steady state concentration of
500 pg/mL.
The Core part of the study will be a double-blind (except for the use of open label active
control moxifloxacin), randomized, placebo-controlled,3 period, 6-sequence, cross-over
design in 72 healthy male and female subjects to evaluate whether exenatide at therapeutic
and supra-therapeutic concentrations has a pharmacological effect on cardiac repolarization
(threshold value >10 msec).
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