An Exploratory Study to Assess the Effects of JNJ-39439335 on the Relief of Pain Using a Thermal-Grill Experimental Model
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This exploratory study will use a thermal-grill experimental model to assess the effects of
      JNJ-39439335 (50 mg, single oral dose) on the relief of pain.
    

Detailed description: 
      This exploratory study will use a thermal-grill experimental model to assess the effects of
      JNJ-39439335 (50 mg, single oral dose) on the relief of pain. The study drug will be tested
      in healthy adult males to find out if a single 50 mg oral dose of JNJ-39439335 will be better
      than placebo (an inactive substance, like a sugar pill) in relieving pain. Study volunteers
      will experience the pain sensation (the illusion of pain) as a result of placing the palm of
      the hand on a small device that consists of harmless warm and cool flat metal bars known as a
      thermal grill. Volunteers will receive JNJ-39439335 or its matching placebo in the study unit
      on Day 1 of each of the 2 treatment periods. The treatment sequence for each volunteer will
      be assigned randomly (like flipping a coin). On the dosing day, the pain sensation will be
      induced and the following outcome measures will be assessed before dosing and at 4 hours
      after dosing: (1) volunteer's heat pain threshold [HPT] and cold pain threshold [CPT], i.e.,
      the hot or the cold temperature at which it begins to elicit pain, (2) the intensity and the
      unpleasantness of the pain sensation resulting from simultaneous application of a warm
      temperature [4 C below HPT] and a cold temperature [4 C above CPT], (3) the intensity of
      non-painful warm and cold sensations following application of temperatures 4 C below HPT or 4
      C above CPT, respectively, and (4) the intensity of pain following application of
      temperatures 2 C above HPT and 2 C below CPT. All of these assessments will be performed at a
      constant room temperature of approximately 21 C. During the trial volunteers will be closely
      monitored for safety, including the evaluation of adverse events, vital signs, 12-lead ECG,
      clinical laboratory testing (hematology and serum chemistry), and full neurological
      examination. Two blood samples for the measurement of JNJ-39439335 plasma concentrations will
      be collected immediately before and immediately after the thermal-grill assessments. At
      approximately 6 hours post-dose, volunteers will be discharged from the study unit. The study
      duration for each volunteer is approximately 9 weeks, including a screening phase that starts
      within 3 weeks before the first study drug administration, a washout of at least 3 weeks
      between the 2 treatment periods, and a final follow-up visit that will take place at
      approximately 3 weeks after the last study drug administration. Each volunteer will receive a
      single oral dose of JNJ-39439335 (50 mg) or placebo tablet on Day 1 of each of the 2
      treatment periods. The study duration for each subject is ~9 weeks.
    

Intervention name(s): JNJ-39439335, Placebo
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: JNJ-39439335; Placebo; Pain; Pain Measurements; Adults; Men