A Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Voluneteers

Healthy Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo Controlled, Cross-Over, Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832546
• Other study ID #: NGX426CLP1003
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2009
• Last updated: January 29, 2009
• Start date: May 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2009
• Source: TorreyPines Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of NGX426 on intradermal capsaicin induced pain in hyperalgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy males, age 21-55

Exclusion Criteria:

• Allergy to study drug

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Hyperalgesia

Intervention

Drug:
• Placebo

• Oral NGX426 (Powder in solution)

Locations

Country	Name	City	State
United States	University of California	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
TorreyPines Therapeutics

Country where clinical trial is conducted

United States,