A Study To Investigate The Effect of JNJ-39758979 on Histamine Induced Itch in Healthy Male Volunteers
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.
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 and/or placebo is given and at 2 and 6 hours after study drug and/or 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 Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Histamine Induced Itch
Intervention
A:JNJ-39758979/Placebo #1, C:Cetirizine/JNJ-39758979 Matching Placebo, B: JNJ-39758979 Matching Placebo /Placebo #2
Status
Completed
Source
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01068223
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Delivery Of Health Care, Integrated
A health care system which combines physicians, hospitals, and other medical services with a health plan to provide the complete spectrum of medical care for its customers. In a fully integrated system, the three key elements - physicians, hospital, and health plan membership - are in balance in terms of matching medical resources with the needs of purchasers and patients. (Coddington et al., Integrated Health Care: Reorganizing the Physician, Hospital and Health Plan Relationship, 1994, p7)
Coombs' Test
Hemagglutination test in which Coombs' reagent (antiglobulin, or anti-human globulin rabbit immune serum) is added to detect incomplete (non-agglutinating, univalent, blocking) antibodies coating erythrocytes. The direct test is applied to red cells which have been coated with antibody in vivo (e.g., in hemolytic disease of newborn, autoimmune hemolytic anemia, and transfusion reactions). The indirect test is applied to serum to detect the presence of antibody (e.g., in detection of incompatibility in cross-matching tests, detection and identification of irregular antibodies, and in detection of antibodies not identifiable by other means).
Cetirizine
A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.
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