MK-8237 (SCH900237) Biomarker Study in Participants With Allergic Rhinitis or Rhinoconjunctivitis (MK-8237-009)

This is an interventional diagnostic trial for Allergic Rhinitis Read More

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