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

Sponsor
TorreyPines Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT00832546
Collaborator
(none)
18
Enrollment
1
Location
3
Arms
4
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: Oral NGX426 (Powder in solution)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Randomized, Placebo Controlled, Cross-Over, Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Volunteers
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

Placebo

Drug: Placebo
Experimental: 2

Powder in solution

Drug: Oral NGX426 (Powder in solution)
Experimental: 3

Drug: Oral NGX426 (Powder in solution)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy males, age 21-55
    Exclusion Criteria:
    • Allergy to study drug

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Diego California United States 92037

    Sponsors and Collaborators

    • TorreyPines Therapeutics

    Investigators

    • Principal Investigator: Mark Wallace, M.D., University of California, San Diego

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00832546
    Other Study ID Numbers:
    • NGX426CLP1003
    First Posted:
    Jan 30, 2009
    Last Update Posted:
    Jan 30, 2009
    Last Verified:
    Jan 1, 2009
    Additional relevant MeSH terms:
    Hyperalgesia

    Study Results

    No Results Posted as of Jan 30, 2009