A Single and Multiple Dose Study to Explore the Safety of JNJ-38224342 in Healthy Patients and Patients With Seasonal Allergies

September 3, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Double-blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics and Pharmacodynamics of JNJ-38224342 in Healthy Patients and in Healthy Patients With Seasonal Allergic Rhinitis

A single and multiple dose study to assess the safety of JNJ 38224342 compared to placebo in healthy volunteers and in volunteers with seasonal allergies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A four-part, single and multiple dose study to investigate the safety of JNJ-38224342 versus placebo in healthy patients and in patients with seasonal allergies. Volunteers (or patients) are randomly assigned to one of four treatment groups or Parts. Part 1 and 2 are randomized (study drug will be assigned by chance) and double-blind (neither the physician nor volunteer knows the identity of the assigned drug). In Part 1 patients receive a single oral dose of either 25, 100, 300, 600, 1250 or 2000 mg of JNJ-38224342 or placebo. In Part 2 patients receive multiple oral doses of either 100, 250, 500 or 700 mg of JNJ-38224342 or placebo administered over 14 days. Part 3 (for male volunteers only) is open-label (all people involved know the identity of the assigned drug), 2-period crossover (meaning that volunteers will receive both treatments at different times) study of the effects of food on JNJ-38224342. Participants will be given a single 100 mg oral dose (either solution or capsule formulation). Part 4 is for patients with seasonal allergies only. The dose of JNJ-38224342 will be determined based on information collected in Parts 1 - 3. Patients that participate in part 4 of the study will also have their nasal passage flushed out with salt water and the contents will be collected. Patients will be asked to remain in the clinic for either 5 days or 18 days depending on what part of the study they are participating in. A physical exam will be performed and a medical history collected. Safety evaluations include adverse event monitoring, blood pressure measurements, ECG and lab work requiring blood and urine samples at various time points throughout the study. Single oral dose of either 25, 100, 300, 600, 1250 or 2000mg of JNJ-38224342 or placebo; Multiple oral dose of either 100, 250, 500 or 700 mg of JNJ-38224342 or placebo administered over 14 days; single oral 100mg dose of JNJ 38224342 as a solution versus capsule with or without food; multiple oral doses of JNJ38224342 or placebo administered for up to 14 days where the number of days dosed, actual dose levels, food requirements will be determined based on the data from Parts 1, 2, and 3

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-smokers
  • If male, willing to use an acceptable method of birth control for duration of study and for 90 days post study
  • Females must be post menopausal, surgically sterilized and cannot be pregnant or lactating (all parts of study)
  • Have a clinical history of allergic rhinitis during the ragweed pollen season and a positive skin test for ragweed allergy are required (for part 4 of study only)

Exclusion Criteria:

  • Clinically significant medical illnesses, laboratory or ECG findings
  • History of allergy to aspirin or nonsteroidal anti-inflammatory drugs
  • history of alcohol or drug abuse within the last 5 years
  • HIV or Hepatitis B or C positive
  • Receipt of an investigational drug or use of an investigational medical device within the last month
  • History of asthma or severe respiratory infection or disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
JNJ38224342/placebo one of six (6) single ascending doses (25 100 300 600 1250 or 2000 mg) of JNJ 38224342 or matching placebo up to four (4) additional cohorts consisting of healthy male volunteers may be added
Drug: JNJ38224342/placebo
up to four (4) additional cohorts consisting of healthy male volunteers may be added
Drug: JNJ38224342/placebo
.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added
Drug: JNJ38224342/placebo
one of six (6) single ascending doses (25, 100, 300, 600, 1250 or 2000 mg) of JNJ 38224342 or matching placebo
Experimental: 002
JNJ38224342/placebo multiple ascending oral doses (100 250 500 750 mg) of JNJ 38224342 or matching placebo administered for 14 consecutive days in healthy male or female volunteers.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added
Drug: JNJ38224342/placebo
up to four (4) additional cohorts consisting of healthy male volunteers may be added
Drug: JNJ38224342/placebo
.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added
Drug: JNJ38224342/placebo
one of six (6) single ascending doses (25, 100, 300, 600, 1250 or 2000 mg) of JNJ 38224342 or matching placebo
Experimental: 003
JNJ38224342 single oral 100mg dose of JNJ 38224342 as a solution versus a single oral dose of JNJ 38224342 as a capsule formulation with and without food in healthy male volunteers
Drug: JNJ38224342
multiple ascending oral doses (100, 250, 500, 750 mg) of JNJ 38224342 or matching placebo, administered for 14 consecutive days in healthy male or female volunteers
Experimental: 004
JNJ38224342/placebo multiple oral doses of JNJ38224342 or matching placebo administered for up to 14 consecutive days in male and female volunteers number of days dosed and actual dose levels food requirements and regimens will be determined based on the data from Parts 1 2 and 3.
Drug: JNJ38224342/placebo
up to four (4) additional cohorts consisting of healthy male volunteers may be added
Drug: JNJ38224342/placebo
.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added
Drug: JNJ38224342/placebo
one of six (6) single ascending doses (25, 100, 300, 600, 1250 or 2000 mg) of JNJ 38224342 or matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess safety and pharmacokinetics of single and multiple oral ascending doses of JNJ-38224342 with and without food in healthy volunteers and patients with seasonal allergies as determined by occurrence of adverse events, lab test results, vital sign
Time Frame: from the time of the first dose to 7-11 days after the last dose administered
from the time of the first dose to 7-11 days after the last dose administered

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the results of biomarker assessments performed during Parts 2 and 4 of the trial.
Time Frame: from 7-11 days post the last administered dose
from 7-11 days post the last administered dose
Evaluate the effectiveness of treatment based on nasal symptoms for Part 4.
Time Frame: from 7-11 days post the last administered dose
from 7-11 days post the last administered dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 21, 2010

First Posted (Estimate)

January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 3, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016798

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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