MK-8237 (SCH900237) Biomarker Study in Participants With Allergic Rhinitis or Rhinoconjunctivitis (MK-8237-009)
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Intervention: MK-8237; Placebo; NAC
Intervention description: A single tablet of MK-8237 with 12 DU, administered sublingually, at approximately the same time each day for 84 days (+/- 5 days); A single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days); 0.1 mL fixed volume of 10,000 BU/mL of HDM extract is delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1; and in Part 2 on Days -14, 56 and 84
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the effect on various biomarkers of treatment with
      MK-8237 in participants with allergic rhinitis or rhinoconjunctivitis. In Part 1 of the study
      healthy participants undergo nasal allergen challenge (NAC) with house dust mite (HDM)
      extract in order to verify the operational performance of NAC and associated sample
      collection methods. Part 2, the main study, is a placebo controlled, double blind study of
      participants with HDM-induced allergic rhinitis or rhinoconjunctivitis. The primary
      hypotheses are that the changes from baseline in post-allergen challenge HDM-specific
      Immunoglobulin G4 (IgG4) and Immunoglobulin E blocking factor (IgE-BF) are greater after
      treatment with MK-8237 than after treatment with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        Part 1:

          -  healthy participants

          -  has a Body Mass Index (BMI) =< 30 kg/m^2

          -  female of reproductive potential remains abstinent or uses two acceptable methods of
             birth control from 2 weeks before first allergen challenge to 2 weeks after last
             allergen challenge; alternatively hormonal contraception may be used.

        Part 2:

          -  has a Body Mass Index (BMI) =< 38 kg/m^2

          -  has a clinical history of allergic rhinitis/rhinoconjunctivitis to HDM for at least
             one year, and used medication to relieve symptoms within the last year

          -  does not have asthma, or has mild controlled asthma not requiring regular use over the
             12 months prior to screening of any corticosteroids

          -  female of reproductive potential remains abstinent or use two acceptable methods of
             birth control from 2 weeks before first allergen challenge to at least 2 weeks after
             last allergen challenge or last dose of study drug, whichever is longer

          -  has not smoked or used tobacco for the prior 6 months, and agrees not to during study

        Exclusion Criteria:

        Parts 1 and 2:

          -  is experiencing at the first NAC visit, symptoms from an upper or lower respiratory
             tract infection (viral or bacterial)

          -  has participated within the prior 3 months in another investigational study (that
             included an investigational drug or agent)

          -  is directly associated with the administration of the study or is related to the
             investigational study staff

          -  is mentally or legally incapacitated, has significant emotional problems or has a
             history of clinically significant psychiatric disorder within the past 5 years

          -  has a history of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary or major
             neurological (including stroke and chronic seizures) abnormalities or diseases

          -  has a history of cancer

          -  has a history of significant intolerability to drugs or food

          -  is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV

          -  had major surgery or lost 1 unit (500 mL) of blood within the prior 4 weeks

          -  has a clinical history of chronic sinusitis during the prior 2 years

          -  has any nasal condition (e.g. nasal polyposis) that could confound efficacy or safety
             assessments

          -  is pregnant or expects to conceive during the study period

          -  is a nursing mother

          -  consumes more than 3 glasses of alcoholic beverages per day

          -  regularly uses any illicit drug, or has a history of drug or alcohol abuse within the
             prior 6 months

        Part 2 only:

          -  is experiencing allergic rhinoconjunctivitis exacerbation at Screening NAC

          -  consumes excessive daily amounts of caffeinated beverages

          -  has a known history of allergy, hypersensitivity or intolerance to investigational
             medicines

          -  is sensitized and regularly exposed to animal dander and molds in the home or
             workplace in a manner that might interfere with the study in the opinion of the
             investigator

          -  is sensitized and regularly exposed to seasonal allergens such as Birch or grass
             pollen (sensitized but out of season is acceptable however)

          -  has a history of chronic urticaria and/or angioedema within the prior 2 years

          -  has had previous immunotherapeutic treatment with any HDM allergen for more than 1
             month during the prior 3 years

          -  is receiving any specific immunotherapy within prior 60 days

          -  has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy
             due to an unknown cause or an inhalant allergen