The study in 48 young healthy subjects, of whom 36 received EVT 101, showed that the drug was well absorbed, extremely well tolerated with no significant adverse events, and had a good pharmacokinetic profile consistent with once- or twice-daily oral dosing.
EVT 101 is a selective antagonist of the NMDA receptor. The positive safety profile of the drug suggested in this trial is significant as non-selective NMDA receptor antagonists are associated with an unfavorable side-effect profile.
The company has now moved the drug into the multiple ascending dose stage of the phase I study in both young and elderly volunteers. Evotec said that it expects to publish final results of the complete phase I trials for EVT 101 in the third quarter of 2006.