Status:
COMPLETED
MK-8237 (SCH900237) Biomarker Study in Participants With Allergic Rhinitis or Rhinoconjunctivitis (MK-8237-009)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
ALK-Abelló A/S
Conditions:
Allergic Rhinitis
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 particip...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01852825
Start Date
November 27 2013
End Date
August 3 2015
Last Update
March 15 2019
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