A Randomised, Double-blind, Placebo-controlled, Dose Ascending, Five-way Crossover Study, to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a Single Administration of Three Inhaled Doses (25, 100 and 400 µg) of GW642444M
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre, placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.
Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical laboratory safety tests, collection of adverse events and blood samples.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GW642444M 12.5
干预措施: GW642444M (Drug)
GW642444M 100mcg
干预措施: GW642444M (Drug)
GW642444M 400mcg
干预措施: GW642444M (Drug)
GW642444H 100mcg
干预措施: GW642444H (Drug)
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Adverse events
时间窗: throughout study
Mean change from baseline FEV1 24 hours after dosing.
时间窗: Day 1, on 5 separate occasions
Laboratory safety tests
时间窗: throughout study
Holter monitoring
时间窗: throughout study
Vital signs and 12-lead ECG)
时间窗: throughout study
Supine systolic and diastolic blood pressure and supine heart rate
时间窗: Day 1 on 5 separate occasions
QTc(B)and QTc(F)
时间窗: Day 1 on 5 separate occasions
次要结局
- Mean change from baseline(0-4h)potassium.(Day 1 on 5 separate occasions)
- Glucose Max increase from baseline(Day 1 on 5 separate occasions)
- Potassium Max decrease from baseline(Day 1 on 5 separate occasions)
- Weighted mean change from baseline (0-4h)glucose(Day 1 on 5 separate occasions)
- Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR(Day 1 on 5 separate occasions)