Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
- Registration Number
- NCT01370317
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo for MK-1029 - MK-1029 MK-1029 -
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced One or More Adverse Events 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 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 Outcome Measures
Name Time Method 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 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.
Time to Maximum Plasma Concentration (Tmax) of MK-1029 Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose 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.
Maximum Plasma Concentration (Cmax) of MK-1029 Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose 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.
Trial Locations
- Locations (4)
MSD (Pty) LTD South Africa
🇿🇦Midrand, South Africa
Merck Sharp & Dohme
🇦🇺North Ryde, Australia
Call for Information
🇺🇸Rolling Hills Estates, California, United States
Merck Sharp & Dohme (New Zealand) Ltd.,
🇳🇿Wellington, New Zealand