A Study To Investigate The Effect of JNJ-39758979 on Histamine Induced Itch in Healthy Male Volunteers
Condition: Histamine Induced Itch
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of JNJ-39758979 compared to placebo on
      histamine induced itch in healthy male volunteers.
    

Detailed description: 
      The goal of this study is to evaluate the effect and safety of a single oral dose of
      JNJ-39758979 on histamine-induced itch and hive in 24 healthy male volunteers. This is a
      three-treatment, double-blind (neither the volunteer nor the study physician will know the
      identity of the treatment), cross-over (each volunteer receives all three treatments) study.
      The study is also randomized, meaning that the order in which treatments are given is
      determined randomly (by chance, like flipping a coin). The total participation time is
      approximately 8 to 9 weeks, which includes a screening visit, three treatment periods, two
      wash-out periods (breaks), and a follow-up visit after the third treatment period. All three
      treatment periods require a 2-day stay in the clinic. Volunteers will have a histamine test
      at the screening visit and three times during each treatment period (total of 10 tests). The
      histamine test consists of an injection of a small amount of histamine solution into the
      upper layer of the skin, which may cause itchiness, a flare response (redness on the skin)
      and wheal response (elevated bump in the skin) lasting for 30 to 60 minutes. Volunteers will
      be blindfolded during the procedure and asked to rate the severity of the itch. The areas of
      the wheal and flare will be measured by a laser scanner, which will not cause harm to the
      volunteer. During the treatment periods, volunteers will receive the histamine test on the
      day before study drug and/or placebo is given and at 2 and 6 hours after study drug and/or
      placebo is given. During the study, safety evaluations, which will include ECGs (a cardiac
      function test) and vital signs, will be performed, and side effects will be monitored. Blood
      and urine samples will be collected at the screening visit, during the first day of each
      treatment period in the clinic and at the follow-up visit for evaluation. Volunteers will
      receive single doses of 600mg JNJ-39758979, placebo, and 10mg cetirizine in random order over
      three treatment periods. The first two treatment periods will be followed by an approximately
      14 day wash-out period.
    

Intervention name(s): A:JNJ-39758979/Placebo #1; C:Cetirizine/JNJ-39758979 Matching Placebo; B: JNJ-39758979 Matching Placebo /Placebo #2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of JNJ-39758979 600 mg and Placebo; JNJ-39758979 Matching Placebo and Placebo #2; A single dose of 2 different Placebos
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cetirizine, CR016609