Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: MK-1029; Placebo for MK-1029
Intervention description: Five (5) X 100 mg capsules, orally, once daily for 28 days; Five (5) X 100 mg capsules, orally, once daily for 28 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose
      treatment with MK-1029 in adults with mild to moderate persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  If female, must be of non-childbearing potential

          -  Have a history of mild to moderate asthma for at least 6 months

          -  Other than asthma, in general good health

          -  Able to perform reproducible pulmonary function testing

          -  Is a nonsmoker and/or has not used nicotine or nicotine-containing products for at
             least 12 months

          -  Have body mass index (BMI) ≥17 kg/m^2, but ≤35 kg/m^2

        Exclusion Criteria:

          -  Demonstrate a decrease in absolute forced expiratory volume in 1 second (FEV1) of >20%
             from the Screening Visit to the Baseline Visit

          -  Experience a decrease in AM or PM peak expiratory flow (PEF) below the Stability Limit
             on any 2 consecutive days prior to the Baseline Visit

          -  Require the use of >8 inhalations per day of short-acting beta2-agonist metered dose
             inhaler (MDI) or >2 nebulized treatments per day of 2.5 mg albuterol, on any 2
             consecutive days from the Screening Visit up to the Baseline Visit

          -  Experience an exacerbation defined as a clinical deterioration of asthma, as judged by
             the clinical investigator, that results in emergency treatment, hospitalization due to
             asthma, or treatment with additional, excluded medication (other than short-acting
             beta agonists [SABA]) at any time from the Screening Visit up to the Baseline Visit

          -  Have been hospitalized for treatment of asthma or required oral corticosteroids for
             treatment of asthma within the past 6 months, or has ever required ventilator support
             for respiratory failure secondary to asthma

          -  Require the chronic use of high-dose inhaled corticosteroids

          -  Have been diagnosed with chronic obstructive pulmonary disease (COPD) or any other
             clinically relevant lung disease, other than asthma

          -  Have a history of any illness that might confound the results of the study or poses
             additional risk to the participant

          -  Have had recent (within 4 weeks of first dose) or ongoing upper or lower respiratory
             tract infection

          -  Is nursing

          -  Have a history of significant multiple and/or severe allergies (including latex
             allergy), or has had an anaphylactic reaction or significant intolerability to
             prescription or non-prescription drugs or food