Results
Overall, mesdopetam was well tolerated up to 120 mg single dose and up to 80 mg upon multiple dosing. AEs were mainly related to the nervous system and were dose dependent. No SAEs occurred and no AEs led to withdrawal.
The results of the SAD and the MAD parts indicated dose- and time-independent pharmacokinetics with rapid absorption, maximum plasma levels generally reached within 2 hours after dosing. The average terminal half-life of mesdopetam ranged from 6.4 to 7.1 hours in the SAD part, and 6.3 to 7.3 hours in the MAD part. No accumulation was observed upon multiple dosing.
Safety findings were unremarkable with no changes demonstrated in vital signs, ECG parameters or physical examination. Mesdopetam produced a dose-dependent increase in plasma prolactin, compatible with target engagement.