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.