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临床试验/NCT00522678
NCT00522678已完成1 期

A Randomised, Double Blind, Placebo Controlled, Parallel Group, 14 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled GW685698X Containing Magnesium Stearate in Healthy Subjects

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2007年2月15日最近更新:
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
36
试验地点
1
主要终点
Safety and tolerability: Vital signs: systolic and diastolic blood pressure (BP), heart rate (HR) 12-lead ECG including QT, QTc, PR and QRS intervals PEFR Laboratory safety tests (clinical chemistry, haematology, urinalysis) Adverse events

研究概览

简要总结

GW685698X is a novel glucocorticoid receptor agonist that is being developed as an orally inhaled treatment for asthma. In previous studies inhaled GW685698X was administered as a dry powder containing either lactose alone or lactose and cellobiose octaacetate. However, future dry powder GW685698X formulations will contain lactose and magnesium stearate. This study will be the first administration of this new GW685698X dry powder formulation in man and will provide safety and tolerability data to support the further development of this formulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

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

入选标准

  • Healthy Volunteers,
  • Aged 18-65
  • Male and females (females of non-child bearing potential or who meet the contraception criteria).
  • BMI - 19-31 kg/m2

排除标准

  • History of breathing problems

研究组 & 干预措施

Cohort A

Experimental

In Cohort A, subjects will be randomized (3:1) to receive once daily doses of GW685698X 400 microgram (mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

干预措施: GW685698X (Drug)

Cohort A

Experimental

In Cohort A, subjects will be randomized (3:1) to receive once daily doses of GW685698X 400 microgram (mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

干预措施: Placebo (Drug)

Cohort B

Experimental

In Cohort B, subjects will be randomized (3:1) to receive once daily doses of GW685698X (600 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

干预措施: GW685698X (Drug)

Cohort B

Experimental

In Cohort B, subjects will be randomized (3:1) to receive once daily doses of GW685698X (600 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

干预措施: Placebo (Drug)

Cohort C

Experimental

InIn Cohort C, subjects will be randomized (3:1) to receive once daily doses of GW685698X (800 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

干预措施: GW685698X (Drug)

Cohort C

Experimental

InIn Cohort C, subjects will be randomized (3:1) to receive once daily doses of GW685698X (800 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

干预措施: Placebo (Drug)

结局指标

主要结局

Safety and tolerability: Vital signs: systolic and diastolic blood pressure (BP), heart rate (HR) 12-lead ECG including QT, QTc, PR and QRS intervals PEFR Laboratory safety tests (clinical chemistry, haematology, urinalysis) Adverse events

时间窗: Up to Day 16

次要结局

  • Plasma concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) for GW685698X on Day 1 and Day 14. Weighted mean serum cortisol, (0-24 h) on Day 14.(Weighted mean serum cortisol, (0-24 h) on Day 14)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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