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

NCT ID: NCT01054352

Last Updated: 2013-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-03-31

Brief Summary

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.

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

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal allergies; Allergic rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

JNJ38224342/placebo

Intervention Type: DRUG

one of six (6) single ascending doses (25, 100, 300, 600, 1250 or 2000 mg) of JNJ 38224342 or matching placebo

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

Group Type: EXPERIMENTAL

JNJ38224342/placebo

Intervention Type: DRUG

up to four (4) additional cohorts consisting of healthy male volunteers may be added

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

Group Type: EXPERIMENTAL

JNJ38224342

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

JNJ38224342/placebo

Intervention Type: DRUG

.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added

Interventions

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

Intervention Type: DRUG

JNJ38224342/placebo

up to four (4) additional cohorts consisting of healthy male volunteers may be added

Intervention Type: DRUG

JNJ38224342/placebo

.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added

Intervention Type: DRUG

JNJ38224342/placebo

one of six (6) single ascending doses (25, 100, 300, 600, 1250 or 2000 mg) of JNJ 38224342 or matching placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

CR016798

Identifier Type: -

Identifier Source: org_study_id