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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2008

Interventions

  • Drug: Placebo
  • Drug: Oral NGX426 (Powder in solution)

Arms, Groups and Cohorts

  • Placebo Comparator: 1
    • Placebo
  • Experimental: 2
    • Powder in solution
  • Experimental: 3

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy males, age 21-55 Exclusion Criteria:

  • Allergy to study drug

Gender Eligibility: Male

Minimum Age: 21 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • TorreyPines Therapeutics
  • Provider of Information About this Clinical Study
    • Susan Mellberg, R.N., M.B.A.; VP, Project Management, TorreyPines Therapeutics, Inc.
  • Overall Official(s)
    • Mark Wallace, M.D., Principal Investigator, University of California, San Diego

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