This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
100
Novartis Investigational Site
Austin, Texas, United States
Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo.
Time frame: 24 hours
Change in concentration of exposure-response AEB071 and AEE800 (a metabolite of AEB071) concentrations compared to cardiac repolarization intervals
Time frame: 24 hours
Tolerability of 300 and 900 mg of AEB071.
Time frame: 72 hours
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