An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Placebo; JNJ-39220675; Pseudoephedrine
Intervention description: Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.; Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.; Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Intervention MeSH terms: Pseudoephedrine; Ephedrine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Allergy; Rhinitis; Allergic Rhinitis; JNJ-39220675; Pseudoephedrine

Summary:

      The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and
      pseudoephedrine compared to placebo (medication with no active ingredients) in participants
      with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen,
      dust or animal hair).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a clinical history of seasonal allergic rhinitis with seasonal
             onset and offset of nasal allergy symptoms at least during each of the last two
             ragweed allergy seasons

          -  Participants must have documentation of a positive skin test within 12 months of
             Screening to ragweed allergen defined by a positive case history and a positive skin
             prick and/or intradermal test (allergy tests performed by injecting allergy-causing
             substances underneath the skin to see if they cause a reaction) for ragweed allergen

          -  Female participants must not be pregnant, lactating or be able to become pregnant

          -  Male participants must consent to use a medically acceptable method of contraception
             throughout the entire study period and for 3 months after the study is completed

          -  Participants with body mass index between 18 and 32 kilogram per square meter

        Exclusion Criteria:

          -  Participants with clinically significant physical findings of nasal anatomical
             deformities

          -  Participants with a history of risk factors for torsades de pointes (heart failure,
             hypokalemia, family history of long QT syndrome), use of concomitant medications that
             prolong the QT or QTc interval or an abnormal 12-lead electrocardiogram except for
             clinically non-significant bradycardia

          -  Participants with history of exposure to an investigational treatment within the 30
             days before the Screening Visit, or has ever taken JNJ-39220675 previously

          -  Participants with a history of clinically significant allergies, especially known
             hypersensitivity or intolerance to any drug or known allergy to the study drug or any
             of the excipients of the formulation

          -  Participants with a history of severe respiratory infection or disorder, epilepsy or
             seizures, coronary heart disease, uncontrolled hypertension, or other clinically
             significant cardiovascular disease, or history of a positive test for Human
             immuno-deficiency (HIV), Hepatitis B or Hepatitis C