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

NCT01054352 | Completed Phase 1

• 1 other identifier: CR016798
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal allergies; Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

  from the time of the first dose to 7-11 days after the last dose administered

Secondary Outcomes (2)

• Evaluate the results of biomarker assessments performed during Parts 2 and 4 of the trial.

  from 7-11 days post the last administered dose

• Evaluate the effectiveness of treatment based on nasal symptoms for Part 4.

  from 7-11 days post the last administered dose

Study Arms (4)

001

EXPERIMENTAL

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

002

EXPERIMENTAL

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

003

EXPERIMENTAL

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

004

EXPERIMENTAL

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

Interventions

JNJ38224342 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

003

JNJ38224342/placebo DRUG

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

002

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Mississauga, Ontario, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 22, 2010
• Study Start: February 1, 2010
• Study Completion: March 1, 2011
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

CA (1)