A Multicenter Randomized Clinical Trial to Study the Effects of Single Doses of MK-8351 on the Early Asthmatic Response to a Lung Allergen Challenge
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- AUC0-3hr of FEV1 Percent Change From Baseline
研究概览
简要总结
The primary hypothesis of the study is single doses of MK-8351 will reduce the baseline early asthmatic response (EAR) as assessed by area under the curve from 0-3 hours (AUC0-3hr) of forced expiratory volume (FEV1) when compared to placebo.
详细描述
This is a randomized, placebo-controlled, 4-period study. Eligible patients will undergo a single-blind phase in Period 1, followed by 3 periods during which they will receive low-dose MK-8351, high-dose MK-8351, or matching placebo as a single dose in a random sequence crossover study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females of non-childbearing potential (at least 1 year post-menopausal, post-hysterectomy, post-oophorectomy, or with tubal ligation);
- •Males with a female partner of childbearing potential must agree to use a medically acceptable method of contraception during and up to 120 days after the last dose of study medication;
- •Body Mass Index (BMI) >=17 kg/m^2 and <=33 kg/m^2
- •Non-smoker and non-user of nicotine or nicotine-containing products for at least 6 months prior to enrollment;
- •History of allergen-induced asthma for at least 6 months prior to enrollment;
- •Able to perform reproducible pulmonary function testing;
- •Positive methacholine challenge test prior to receiving study medication;
- •Allergic response to house dust mite allergen or standardized cat pelt or hair allergen extract;
- •Ability to tolerate sputum induction and to produce adequate sputum.
排除标准
- •History of clinically significant disease or disorder;
- •History of malignancy;
- •History of significant multiple and/or severe allergies;
- •History of milk or lactose allergies or intolerance;
- •History of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
- •Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies;
- •History of major surgery within 3 months prior to enrollment;
- •Participation in another investigational trial within 4 weeks of screening;
- •Lactating females;
- •Inability to refrain from, or anticipates the use of, any medication including herbal remedies during the trial period;
- •History of receiving anti-immunoglobulin E (IgE) or immunotherapy;
- •History of serious allergies to drug or a history of hypersensitivity to inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication;
- •History of hospitalization for asthma-related illness within 3 months of screening;
- •History of emergent care more than twice in the last 12 months for asthma-related illness;
- •History of life-threatening asthma;
- •Consumes >4 glasses of alcoholic beverage per day;
- •Consumes >6 servings of coffee, tea, cola, energy drinks or other caffeinated beverages per day;
- •History or or current use of illicit drugs within past 24 months.
研究组 & 干预措施
Low-Dose MK-8351
Low-dose MK-8351 administered as single inhaled dose.
干预措施: Low-Dose MK-8351 (Drug)
High-Dose MK-8351
High-dose MK-8351 administered as a single inhaled dose.
干预措施: High-Dose MK-8351 (Drug)
Placebo to MK-8351
Matching placebo to low-dose or high-dose MK-8351 administered as a single inhaled dose.
干预措施: Placebo to MK-8351 (Drug)
结局指标
主要结局
AUC0-3hr of FEV1 Percent Change From Baseline
时间窗: 3 Hours
Number of Participants Experiencing Adverse Events (AEs)
时间窗: Up to 14 Days
Number of Participants Discontinuing Study Treatment Due to AEs
时间窗: Up to 72 Hours
次要结局
- AUC0-24h of MK-8351(Up to 24 Hours Post-Dose)
- AUC0-last of MK-8351(Up to 72 Hours Post-Dose)
- AUC0-∞ of MK-8351(Up to 72 Hours Post-Dose)
- Maximum Plasma Concentration (Cmax) of MK-8351(Up to 72 Hours Post-Dose)
- Time to Maximum Plasma Concentration (Tmax) of MK-8351(Up to 72 Hours Post-Dose)
- Apparent Half-Life (t1/2) of MK-8351(Up to 72 Hours Post-Dose)