Ignite Creation Date:
2024-05-05 @ 9:58 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01006304
Status:
COMPLETED
Last Update Posted:
2010-07-02
First Post:
2009-10-29
Brief Title:
An Exploratory Study to Assess the Effects of JNJ-39439335 on the Relief of Pain Using a Thermal-Grill Experimental Model
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 volunteers heat pain threshold HPT and cold pain threshold CPT ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None