A Study To Investigate The Effect of JNJ-39758979 on Histamine Induced Itch in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01068223
First received: February 11, 2010
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to investigate the effect of JNJ-39758979 compared to placebo on histamine induced itch in healthy male volunteers.


Condition Intervention Phase
Histamine Induced Itch
Drug: A:JNJ-39758979/Placebo #1
Drug: C:Cetirizine/JNJ-39758979 Matching Placebo
Drug: B: JNJ-39758979 Matching Placebo /Placebo #2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Participant-assessed pruritis score following histamine challenge [ Time Frame: at 30 second intervals for the first 5 minutes and then at 1 minute intervals through 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of single oral dose of JNJ-39758979 (600mg) on histamine-induced wheal and flare in healthy volunteers [ Time Frame: at 10 minutes following histamine challenge ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2010
Study Completion Date: May 2010
Arms Assigned Interventions
Experimental: 001
A:JNJ-39758979/Placebo #1 Single oral dose of JNJ-39758979 600 mg and Placebo
Drug: A:JNJ-39758979/Placebo #1
Single oral dose of JNJ-39758979 600 mg and Placebo
Placebo Comparator: 002
B: JNJ-39758979 Matching Placebo /Placebo #2 A single dose of 2 different Placebos JNJ-39758979 Matching Placebo and Placebo #2
Drug: B: JNJ-39758979 Matching Placebo /Placebo #2
A single dose of 2 different Placebos
Active Comparator: 003
C:Cetirizine/JNJ-39758979 Matching Placebo Single oral dose of 10mg cetirizine and JNJ-39758979 Matching Placebo
Drug: C:Cetirizine/JNJ-39758979 Matching Placebo
JNJ-39758979 Matching Placebo and Placebo #2

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smoker or ex-smoker for at least 3 months
  • Should generally be in good health
  • Must have negative urine alcohol and drug tests
  • Must consent to utilize a medically acceptable method of contraception throughout the study and for three months after the last dose of study drug and not donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion Criteria:

  • Positive for hepatitis B, hepatitis C, or HIV
  • History of drug or alcohol abuse within the past two years
  • Known allergies, hypersensitivity, or intolerance to cetirizine (Zyrtec)
  • Any confirmed significant reactions against any drug
  • Active skin diseases
  • History of atopic disease or evidence of allergen sensitization by skin prick testing to common aeroallergens
  • Use of antihistamines or antidepressants with antihistamine properties within the last 7 days, prescription medication within the last 14 days or Monoamine oxidase inhibitors (MAOIs) within the last 21 days
  • Have received an investigational drug or device within the past 3 months
  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: NCT01068223

Locations
United Kingdom
Harrow, United Kingdom
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: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01068223     History of Changes
Other Study ID Numbers: CR016609
Study First Received: February 11, 2010
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Cetirizine, CR016609

Additional relevant MeSH terms:
Histamine
Cetirizine
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on July 31, 2014