Effects of S44819 on GABAergic system measured by Transcranial Magnetic Stimulation (TMS) in healthy young male volunteers. A phase I, monocentric, randomised, double-blind, placebo-controlled, cross-over study, with 3 treatment periods (placebo, S 44819 50 mg, S44819 100 mg)

15.04.2015 bis 31.12.2015

Primary objective:
To assess by electromyography (EMG) the effects of S 44819 (50 mg and 100 mg), a specific alpha-5 GABAAR antagonist, on short interval intracortical inhibition (SICI), a motor evoked potential induced by paired-pulse transcranial magnetic stimulation (TMS) in healthy human subjects.
Secondary objectives:
- To assess by electroencephalography (EEG) the effects of S 44819 (50 mg and 100 mg) on TMS-evoked EEG potentials (including N45 and N100).
- To assess the safety and tolerability of S 44819 (50 mg and 100 mg) after single oral administration in healthy male volunteers.
- To measure the concentration in plasma of S 44819 and its metabolites (if applicable).
- If relevant to investigate the potential impact of plasma concentration of S 44819 and its metabolites (if applicable) on the PD endpoints (PK/PD analysis).