An Exploratory Study to Assess the Effects of JNJ-39439335 on the Relief of Pain Using a Thermal-Grill Experimental Model

NCT ID: NCT01006304

Last Updated: 2010-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-06-30

Brief 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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Interventions

JNJ-39439335, Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Other Identifiers

CR016666

Identifier Type: -

Identifier Source: org_study_id