Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma
Overview
- Phase
- Phase 1
- Intervention
- MK-1029
- Conditions
- Asthma
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 27
- Locations
- 4
- Primary Endpoint
- Number of Participants Who Experienced One or More Adverse Events
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
MK-1029
Intervention: MK-1029
Placebo
Intervention: Placebo for MK-1029
Outcomes
Primary Outcomes
Number of Participants Who Experienced One or More Adverse Events
Time Frame: Up to 42 days after initial dose of study treatment
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.
Number of Participants Who Discontinued Study Treatment Due to An Adverse Event
Time Frame: Up to 28 days after initial dose of study treatment
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.
Secondary Outcomes
- Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029(Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose)
- Time to Maximum Plasma Concentration (Tmax) of MK-1029(Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose)
- Maximum Plasma Concentration (Cmax) of MK-1029(Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose)