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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01006304
First received: October 29, 2009
Last updated: July 1, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Pain
Drug: JNJ-39439335, Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Effects of JNJ-39439335 (a TRPV1 Antagonist) in Healthy Male Adult Subjects on the Paradoxical Pain Induced by a Thermal Grill

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The effects of JNJ-39439335 on the relief of paradoxical pain (the illusion of pain) [ Time Frame: at predose and at 4 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effects of JNJ-39439335 on the non-painful cold and warm sensations corresponding respectively to the cold and warm temperatures used to induce paradoxical pain [ Time Frame: at predose and at 4 hours postdose in each of the 2 treatment periods ] [ Designated as safety issue: No ]
  • The effects of JNJ-39439335 on the normal cold- and heat-pain induced by supra-threshold cold and heat stimuli. [ Time Frame: at predose and at 4 hours postdose in each of the 2 treatment periods ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2009
Study Completion Date: June 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006304

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Clinical Leader
ClinicalTrials.gov Identifier: NCT01006304     History of Changes
Other Study ID Numbers: CR016666
Study First Received: October 29, 2009
Last Updated: July 1, 2010
Health Authority: France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ministry of Health

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
JNJ-39439335
Placebo
Pain
Pain Measurements
Adults
Men

ClinicalTrials.gov processed this record on October 23, 2014