NCT01483846

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

A Phase 1b, Single-Site, Randomized, Double-Blind,Placebo-Controlled, Dose-Escalation Study: Safety, Pharmacokinetics, and Antihyperalgesic Activity of Multiple Doses of AV-101 on Capsaicin-Induced Pain in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: VistaGen Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Healthy subjects will be randomized into three dose cohorts (360, 1,080, and 1,440 mg) to receive daily oral doses of AV-101 for 14 consecutive days. Each cohort has 12 subjects on active drug and 4 subjects on placebo. Safety, PK, and antihyperalgesic effects of treatment with AV-101 will be assessed. At the screening visit between Day -28 and Day -7 before randomization, 250 μg of capsaicin will be intradermally delivered into the volar aspect of one forearm. Subjects must report a pain score of at least 4 out of 10 to qualify for the study. On Day 1 and Day 14 the following data are collected: (1) neurosensory testing (thermal sensation, thermal pain, touch, and mechanical pain) on the forearm; (2) neurocognitive evaluation; and (3) 12-lead electrocardiogram, blood pressure, heart rate, respiratory rate, and temperature. PK samples will be collected on Days 1, 2, 14, and 15. The capsaicin-induced pain will be assessed at screening, on Day 1, and Day 14. An intradermal injection of capsaicin into the forearm on Day 1 and Day 14 will be followed by the efficacy measures. On Day 1 before administration of the first dose, subjects will be given a paper diary to record daily self-administration of each dose, concomitant medications, and adverse events during the 14-day treatment period.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	AV-101	Placebo or AV-101 at 360 mg, 1080 mg, or 1440 mg will be dosed once daily for 14 consecutive days.
DRUG	Placebo	Placebo or AV-101 at 360 mg, 1080 mg, or 1440 mg will be dosed once daily for 14 consecutive days.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-12-01
• Last updated: 2012-12-20

Locations

1 site across 1 country: United States