A Randomised, Double Blind, Placebo Controlled Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Profile of Single Inhaled Dry Powder Doses of GSK159802 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Safety & tolerability of single inhaled doses of GSK159802.
研究概览
简要总结
GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which is being developed for once daily treatment of asthma and COPD as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are limited by local administration and also tend to show tachyphylaxis.
The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily administration, given their duration of action. Therefore, there is significant opportunity for a once-daily inhaled medication to improve patient compliance and overall disease management by providing sustained, 24-hour bronchodilation.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subjects receiving treatment sequence 3 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 4 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 1 : Cohort 1
Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 1 : Cohort 1
Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 2 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 2 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 5 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 1 : Cohort 2
Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 1 : Cohort 2
Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 2 : Cohort 2
Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 3 : Cohort 2
Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 4 : Cohort 2
Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 4 : Cohort 2
Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 1 : Cohort 3
Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 2 : Cohort 3
Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 2 : Cohort 3
Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 3 : Cohort 3
Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 4 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 5 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.
干预措施: Placebo (Drug)
Subjects receiving treatment sequence 3 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 4 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 5 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 3 : Cohort 2
Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 1 : Cohort 3
Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 5 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 4 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 3 : Cohort 3
Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 2 : Cohort 2
Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
干预措施: GSK159802 (Drug)
Subjects receiving treatment sequence 1 : Cohort 1
Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 2 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 4 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 3 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 5 : Cohort 1
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 1 : Cohort 2
Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 3 : Cohort 2
Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 2 : Cohort 2
Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 1 : Cohort 3
Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 4 : Cohort 2
Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 2 : Cohort 3
Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 3 : Cohort 3
Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 5 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.
干预措施: Salmeterol (Drug)
Subjects receiving treatment sequence 4 : Cohort 3
Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
干预措施: Salmeterol (Drug)
结局指标
主要结局
Safety & tolerability of single inhaled doses of GSK159802.
时间窗: Up to 71 days
次要结局
- sGaw (Cohorts 1 and 2 only) and FEV1 Systemic & urine pharmacokinetics of GSK159802 and SKF-91300 Heart rate, potassium, glucose, 12-lead ECG & blood pressure(Up to 71 days)