Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: MK-1029
* Drug: Placebo for MK-1029


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-1029<br> | Drug: MK-1029<br>* Five (5) X 100 mg capsules, orally, once daily for 28 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo for MK-1029<br>* Five (5) X 100 mg capsules, orally, once daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced One or More Adverse Events | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to 42 days after initial dose of study treatment | 
| Number of Participants Who Discontinued Study Treatment Due to An Adverse Event | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to 28 days after initial dose of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029 | Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026. | Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose | 
| Maximum Plasma Concentration (Cmax) of MK-1029 | Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026. | Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose | 
| Time to Maximum Plasma Concentration (Tmax) of MK-1029 | Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Tmax of MK-1026. | Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose |