Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01068223
Status:
COMPLETED
Last Update Posted:
2013-09-04
First Post:
2010-02-11
Brief Title:
A Study To Investigate The Effect of JNJ-39758979 on Histamine Induced Itch in Healthy Male Volunteers
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Single-Center Single-Dose Double-Blind Modified-Double-Dummy Placebo and Active-Controlled Randomized Three-Way Six-Sequence Cross-Over Study to Investigate the Effect of JNJ-39758979 on Histamine Induced Pruritus in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2013-09
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:
The purpose of this study is to investigate the effect of JNJ-39758979 compared to placebo on histamine induced itch in healthy male volunteers
Detailed Description:
The goal of this study is to evaluate the effect and safety of a single oral dose of JNJ-39758979 on histamine-induced itch and hive in 24 healthy male volunteers This is a three-treatment double-blind neither the volunteer nor the study physician will know the identity of the treatment cross-over each volunteer receives all three treatments study The study is also randomized meaning that the order in which treatments are given is determined randomly by chance like flipping a coin The total participation time is approximately 8 to 9 weeks which includes a screening visit three treatment periods two wash-out periods breaks and a follow-up visit after the third treatment period All three treatment periods require a 2-day stay in the clinic Volunteers will have a histamine test at the screening visit and three times during each treatment period total of 10 tests The histamine test consists of an injection of a small amount of histamine solution into the upper layer of the skin which may cause itchiness a flare response redness on the skin and wheal response elevated bump in the skin lasting for 30 to 60 minutes Volunteers will be blindfolded during the procedure and asked to rate the severity of the itch The areas of the wheal and flare will be measured by a laser scanner which will not cause harm to the volunteer During the treatment periods volunteers will receive the histamine test on the day before study drug andor placebo is given and at 2 and 6 hours after study drug andor placebo is given During the study safety evaluations which will include ECGs a cardiac function test and vital signs will be performed and side effects will be monitored Blood and urine samples will be collected at the screening visit during the first day of each treatment period in the clinic and at the follow-up visit for evaluation Volunteers will receive single doses of 600mg JNJ-39758979 placebo and 10mg cetirizine in random order over three treatment periods The first two treatment periods will be followed by an approximately 14 day wash-out period
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