Project Effects of S44819 on GABAergic system measured by Transcranial Magnetic Stimulation (TMS) in healthy young male…

Basic data

Title:
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)
Duration:
15/04/2015 to 31/12/2015
Abstract / short description:
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).
Keywords:
Motorischer Kortex
Erregbarkeit
Transkranielle Magnetstimulation (TMS)
Alpha-5 GABA-A Rezeptor Antagonist
Inhibition
EEG
electroencephalography, Elektroenzephalografie

Involved staff

Managers

University Department of Neurology
Hospitals and clinical institutes, Faculty of Medicine

Contact persons

Faculty of Medicine
University of Tübingen

Local organizational units

Department of Neurology with Focus on Neurovascular Diseases
University Department of Neurology
Hospitals and clinical institutes, Faculty of Medicine
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