The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.
An ECG is performed after a dose of sotalol on about 100 healthy subjects in order to identify about 20 extreme responders (10 high responders and 10 non responders) assessed as Delta QTcf compare to baseline. The ECG will be measured and the delta QTcf will be calculated on the 20 selected subjects in a second part of the clinical trial, cross over erythromycin/placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
130
4mg/Kg, IV during 20 min once
4mg/Kg, IV during 20 min once
BIOTRIAL
Rueil-Malmaison, France
Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf
Delta QTcf is measured at H0, H0+20 minutes, and H0+1h20, on groups' erythromycin and placebo. QTcf may be adjusted based on the pharmacokinetic data to ensure time of the plasmatic pick is used.
Time frame: 1hour and 20 minutes
Comparison Delta QTcf eryhtromycin-sotalol
compare the effect of erythromycin and sotalol on QT prologation
Time frame: over 3 hours
Assess the effect of erythromycin Twave morphologie changes
Analysis of Qwave morphologic changes
Time frame: 1hour and 20 min
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