A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild or Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK-0476
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Cmax Accumulation Ratio of Montelukast - Multiple Doses
研究概览
简要总结
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate 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
- •Male or female between the ages of 18 and 65
- •Must have mild or moderate asthma (Part III only)
- •Nonsmoker for at least 6 months
排除标准
- •History of stroke, chronic seizures or major neurological disorder
- •You are nursing
- •Drink more than 3 glasses of alcohol a day
- •Have allergy to or not able to tolerate lactose
- •Have a history of drug abuse in the last 5 years
- •Drink more than 6 beverages containing caffeine a day
- •Have had surgery, donated blood or participated in another investigational study in the last 4 weeks
研究组 & 干预措施
Montelukast 0.1 mg
Participants receive Montelukast inhalation powder, 0.1 mg.
- Part I: Administered as a single dose followed by at least a 3-day washout period.
干预措施: Montelukast (Drug)
Montelukast 0.3 mg
Participants receive Montelukast inhalation powder, 0.3 mg.
- Part I: Administered as a single dose followed by at least a 3-day washout period.
干预措施: Montelukast (Drug)
Montelukast 1 mg
Participants receive Montelukast inhalation powder, 1 mg.
- Part I: Administered as a single dose followed by at least a 3-day washout period.
- Part II: Administered once daily (QD) for 5 days followed by at least a 3-day washout period.
干预措施: Montelukast (Drug)
Montelukast 3 mg
Participants receive Montelukast inhalation powder, 3 mg.
- Part I: Administered as a single dose followed by at least a 3-day washout period.
- Part II: Administered QD for 5 days followed by at least a 3-day washout period.
- Part III: Administered QD for 10 days followed by at least a 7-day washout period.
干预措施: Montelukast (Drug)
Montelukast 10 mg
Participants receive Montelukast inhalation powder, 10 mg.
- Part I: Administered as a single dose followed by at least a 3-day washout period.
- Part II: Administered QD for 5 days followed by at least a 3-day washout period.
- Part III: Administered QD for 10 days followed by at least a 7-day washout period.
干预措施: Montelukast (Drug)
Placebo
Participants receive Placebo to Montelukast inhalation powder.
- Part I: Administered as a single dose followed by at least a 3-day washout period.
- Part II: Administered QD for 5 days followed by at least a 3-day washout period.
- Part III: Administered QD for 10 days followed by at least a 7-day washout period.
干预措施: Placebo (Drug)
结局指标
主要结局
Cmax Accumulation Ratio of Montelukast - Multiple Doses
时间窗: up to 10 days after first dose of study drug
The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose
时间窗: Up to 24 hours postdose
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Cmax of Montelukast - Multiple Doses
时间窗: Up to 24 hours postdose
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Time to Cmax (Tmax) of Montelukast - Single Dose
时间窗: Up to 24 hours postdose
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
t1/2 of Montelukast - Multiple Doses
时间窗: Up to 24 hours postdose
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
AUC 0-24hr of Montelukast - Multiple Doses
时间窗: Up to 24 hours postdose
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose
时间窗: Up to 24 hours postdose
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Number of Participants Who Experienced At Least One Adverse Event
时间窗: Up to 14 days after last dose of study drug
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
时间窗: Up to 7 days after last dose of study drug
Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose
时间窗: Up to 24 hours postdose
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Tmax of Montelukast - Multiple Doses
时间窗: Up to 24 hours postdose
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses
时间窗: up to 10 days after first dose of study drug
The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
次要结局
未报告次要终点