an exploratory study to assess the effects of jnj-39439335 on the relief of pain using a thermal-grill experimental model

Conditions: Pain

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.

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.

Eligibility criteria:
inclusion criteria: * healthy man with body-mass-index of 18.5 to 30 kg/m2, inclusive exclusion criteria: * men who smoke or use tobacco within 3 months prior to the first study drug administration, and/or have a positive cotinine test result at screening * and men who are not considered healthy based on the ecg, vital signs, physical examinations, and laboratory tests.

Keywords: jnj-39439335 placebo pain pain measurements adults men