Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain

A Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of AV411 to Assess Its Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in the Treatment of Neuropathic Pain

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00576277

Enrollment

Registered

2007-12-19

Start date

2006-09-30

Completion date

2007-11-30

Last updated

2007-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy

Brief summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of AV411 after single and multiple doses in patients with chronic neuropathic pain due to diabetes.

Interventions

DRUGAV411

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of diabetic neuropathy or complex regional pain syndrome of at least 6 months duration * VAS score of 4 cm or higher at Screening * No clinical abnormality in laboratory and urine analyses * Electrocardiogram within normal limits at Screening * Negative pregnancy test on Study Day 1 for female subjects of childbearing potential * On stable doses of medications, analgesic or others for at least 8 weeks prior to study enrollment * Willing to use barrier contraceptive during the period of the study

Exclusion criteria

* Known hypersensitivity to AV411 or its components * Conditions which might affect drug absorption, metabolism or excretion * Untreated mental illness, current drug addiction or abuse or alcoholism * Donated blood in the past 90 days or have poor peripheral venous access * Platelets \<100,000mm3 or a history of thrombocytopenia * Known or suspected chronic liver disease * GFR \<=90mL/min/1.73m2 (Cockcroft-Gault) * Female subjects who are pregnant or nursing mothers * Received an investigational drug in the past 90 days * Unable to swallow large capsules

Design outcomes

Primary

Measure	Time frame
Safety	—
Tolerability	—
Pharmacokinetic profile	—
Pharmacodynamic profile	—

Secondary

Measure	Time frame
Use of analgesic or adjuvant medications for neuropathic pain	—
Clinical Global Impression of Change	—
Correlation between plasma concentrations of AV411 and pain intensity assessments	—
Brief Pain Inventory	—
Visual Analog Scale	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026