Anavex Life Sciences Corp (AVXL)

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"Ascending single oral doses of 1 mg, 10 mg, 30 mg, 40 mg, 50 mg, and 55 mg AV2-73 were safe and well tolerated in healthy male subjects.
Dizziness was the most frequent adverse event.

There was a clear trend for dose dependence of both frequency and intensity of TEAEs across the AV2-73 dose levels from 1 to 60 mg. Three out of four subjects at 60 mg experienced in total 6 dose limiting TEAEs.


Clinical laboratory parameters, vital signs, and 12-lead ECG evaluation did not show any clinically relevant or dose dependent changes.

Based on frequency and intensity of TEAEs the maximum tolerable dose (MTD) and the minimum intolerable dose (MID) were defined as 55 mg and 60 mg, respectively.

The pharmacokinetic data reveal a rapid and extensive biotrans- formation of AV2-73 to its main metabolite AV19-144 after oral administration.

Linear pharmacokinetics after single oral dosing of 1 mg up to 60 mg AV2-73 can be assumed.

The results of the study demonstrate that the design was suitable both to define MTD and MID of AV2-73 and to describe pharmaco- kinetics after administration of single oral doses from 1 to 60 mg."

That was apparently for healthy males.

"Primary To evaluate the safety and tolerability of AV2-73 following single oral administration of escalating doses in male healthy subjects

Secondary To determine the pharmacokinetics of single oral doses of AV2-73

http://www.anavex.com/my_uploads/2014-11-14_Poster_Anavex_2-73_Phase_1_Study_CNS_Summit_2014.pdf