Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Number of Participants Who Experienced One or More Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MK-1029
干预措施: MK-1029 (Drug)
Placebo
干预措施: Placebo for MK-1029 (Drug)
结局指标
主要结局
Number of Participants Who Experienced One or More Adverse Events
时间窗: 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
时间窗: 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.
次要结局
- 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)