A Two-part Study of the Effects of MK-1029 in Allergen-Challenged Asthmatics (MK-1029-003)
Condition: Asthma
MeSH terms: Asthma
Intervention: MK-1029 10 mg; MK-1029 100 mg; Placebo for MK-1029 10 mg; Placebo for MK-1029 100 mg
Intervention description: Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design; Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design; Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design."; Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This was a 2-part study in participants with allergen-induced asthma. It included a
      procedural pilot component (Part 1). Part 1 tested the key procedures and timing of Part 2;
      no study drug was administered during Part 1. Part 2 included a pre-randomization placebo
      run-in (Period 1) and 3 treatment periods (Periods 2, 3, and 4) during which participants
      were randomized to receive double-blind placebo, MK-1029 60 mg or MK-1029 500 mg in a
      crossover design. The treatment periods were followed by a minimum 21-day washout. Part 2
      assessed allergen-induced sputum eosinophils and allergen-induced late asthmatic response
      (LAR) compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        Parts 1 and 2

          -  Is male or a female of non-childbearing potential

          -  Has a history of allergen-induced asthma for at least 6 months

          -  Is judged to be in good health (other than asthma)

          -  Is able to perform reproducible pulmonary function testing

          -  Has a positive methacholine challenge test on Day -1

          -  Has an allergic response to house dust mite allergen as defined by positive skin prick
             test

          -  Is a nonsmoker and/ or has not used nicotine or nicotine-containing products for at
             least 12 months

          -  Has body mass index (BMI) ≥17 kg/m^2, but ≤33 kg/m^2

        Part 2 only

          -  Must demonstrate a dual airway response to an allergen challenge in Period 1, decrease
             in FEV1 of at least 20% 0 to 2 hours after allergen challenge for early asthmatic
             response (EAR) and a positive late asthmatic response (LAR) to an inhaled allergen
             challenge as defined by a bronchoconstrictive response of at least 15% reduction in
             FEV1 3 to 8 hours after allergen challenge

          -  Can tolerate sputum induction and produce adequate sputum

        Exclusion Criteria:

        Parts 1 and 2

          -  Has a history of any illness that, in the opinion of the study investigator, might
             confound the results of the study or poses additional risk to the participant

          -  Has recent (4 weeks) or ongoing upper or lower respiratory tract infection

          -  Is unable to refrain from or anticipates the use of any medication other than the ones
             permitted in this study

          -  Has taken oral, intramuscular, intra-articular, high-potency topical or orally inhaled
             corticosteroids within 8 weeks

          -  Has taken the following medications outside the washout margins: nasal corticosteroids
             and anti-leukotrienes within 3 weeks; inhaled long-acting β2-agonists, long-acting
             antihistamines (e.g., loratadine, sustained-release agents), intra-nasal
             anticholinergics over-the-counter decongestants within 1 week; short-acting oral
             decongestants, short-acting antihistamines (e.g., chlorpheniramine) within 48 hours

          -  Consumes excessive amounts of alcohol or caffeinated beverages

          -  Has had major surgery, donated or lost 1 unit of blood or participated in another
             investigational study within 3 months

          -  Has a history of severe allergies, or has had an anaphylactic reaction or significant
             intolerability to prescription or non-prescription drugs or food

          -  Is a nursing mother

          -  Has a history of receiving anti-immunoglobulin E (IgE) or immunotherapy

          -  Has a history of serious allergies to drugs or a history of hypersensitivity to
             mometasone furoate or any of its inactive ingredients such as lactose, or inhaled
             salbutamol, antihistamines, or any

        other potential asthma/anaphylaxis rescue medication

        Part 2 only

        - Has a decline in FEV1 of 70% or greater from the post allergen diluent baseline and/or
        FEV1 <1.0L or has symptomatic drop in FEV1 associated with shortness of breath unresolved
        with bronchodilators within a reasonable timeframe (60 minutes) after the allergen
        challenge study in Period 1