NCT00751413已完成1 期
A Multicenter, Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 6 to Less Than 12 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- To evaluate the safety and tolerability of single oral doses of MK0633 in pediatric asthma patients.
研究概览
简要总结
To evaluate the safety, tolerability and plasma levels of single oral doses of MK0633 in pediatric asthma patients ages 6 to less than 12 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has mild to moderate asthma
- •Patient is able to swallow pills
- •Patient is able to have have blood draws
排除标准
- •Patient has required a visit to the hospital or emergency room due to an asthmatic event in the last 3 months
- •Patient has an upper respiratory tract infection (URI)
- •Patient has a history of stroke
- •Patient consumes more than 4 caffeinated beverages per day
研究组 & 干预措施
1
Experimental
MK0633
干预措施: Comparator: MK0633 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single oral doses of MK0633 in pediatric asthma patients.
时间窗: Physical examinations, vital sign measurements, laboratory safety tests (blood chemistry, hematology and urinalysis), urine ß-hCG test, and 12-lead ECGs will be performed at various scheduled time points throughout the study.
次要结局
- To obtain information on plasma pharmacokinetics (e.g., AUC0-inf, Cmax, Tmax, apparent t½,) of MK0633 after a single oral dose administration in pediatric asthma patients(Plasma will be analyzed at specific time-points for MK0633 concentrations. Urine will be collected for the measurement of LTE4 concentration.)
研究者
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