Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers

Summary

This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on capsaicin-induced hyperalgesia will be assessed.

Timeline

Start

2011-12

Primary completion

2012-09

Completion

2012-09

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper there was no significant change in the area under the pain time curve (AUPC) for the spontaneous pain assessment between the treatment and the placebo groups reads as missed primary endpoint PMID 29229209 ↗

paper Although, AV-101 did not reach statistical significance in reducing pain reads as missed primary endpoint PMID 29229209 ↗

release “The data indicate that AV-101 had good bioavailability and a favorable PK profile. "The primary safety and tolerability endpoints of the Phase 1 program were met.” reads as met primary endpoint vistagen.com ↗

Publications

• Wallace M, White A, Grako KA, Lane R, Cato AJ, Snodgrass HR. Randomized, double-blind, placebo-controlled, dose-escalation study: Investigation of the safety, pharmacokinetics, and antihyperalgesic activity of l-4-chlorokynurenine in healthy volunteers. Scand J Pain. 2017 Oct;17:243-251. doi: 10.1016/j.sjpain.2017.05.004. Epub 2017 Jun 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AV-101	Small molecule	360 mg	Oral
Subject	AV-101	Small molecule	1080 mg	Oral
Subject	AV-101	Small molecule	1440 mg	Oral

Indications