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Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects

2017年6月9日 更新者:GlaxoSmithKline

An Open-label, Non-randomised, Three-way Crossover, Single Dose Study to Determine the Absolute Bioavailability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder, in Healthy Subjects

This study is being done to look at the absolute bioavailability of fluticasone furoate and GW642444 inhalation powder when administered in healthy subjects. Bioavailability is determined by measuring the amount of the dose of inhaled medication that reaches the circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared to the medication administered intravenously (where bioavailability is 100%).

研究概览

详细说明

Fluticasone furoate (FF), a novel glucocorticoid, and GW642444, a potent, inhaled longacting, beta2-receptor agonist (LABA), are currently under development in combination for use as a once-daily, inhaled treatment for asthma and chronic obstructive pulmonary disease (COPD). FF is also being developed as a stand-alone product for asthma and GW642444 is also being developed as a stand-alone product and in combination with a novel, long-acting muscarinic antagonist for the treatment of COPD. This study is being performed to determine the absolute bioavailability of both FF and GW642444 when delivered in combination from the novel dry powder inhaler.

研究类型

介入性

注册 (实际的)

16

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New South Wales
      • Randwick、New South Wales、澳大利亚、2031
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 64年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy male or female between 18 and 64 years of age inclusive
  • Body mass index (BMI) within the range 18.5-29 0 kg/m2 (inclusive)
  • Subjects who are current non-smokers
  • AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  • QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block, based on a single ECG value, or an average from three ECGs obtained over a brief recording period
  • No significant abnormality on the Holter ECG at screening
  • FEV1 ≥ 85% predicted at screening.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
  • Subjects who are able to use the inhalation device satisfactorily

Exclusion Criteria:

  • As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg
  • Any history of breathing problems in adult life
  • Pregnant or lactating females
  • The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit
  • Subjects with recent history (within 6 months) of pneumonia
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
  • Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate)
  • History of milk protein allergy
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety
  • The subject has taken oral corticosteroids less than 8 weeks before the screening visit
  • The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit
  • History of alcohol/drug abuse or dependence within 12 months of the study
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • The subject has tested positive for HIV antibodies
  • A positive pre-study urine drug screen or when randomly tested during the study
  • Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit.
  • Positive urine cotinine test at screening
  • Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication
  • Unwillingness or inability to follow the procedures outlined in the protocol
  • Subject is mentally or legally incapacitated

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:非随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Treatment period 1
Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder given once daily in the morning on Day 1 of Treatment period 1
Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning
其他:Treatment Period 2
Single IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2
Single IV dose of FF (250mcg)
其他:Treatment Period 3
Single IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3
Single IV dose of GW642444 (55mcg)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Absolute bioavailability of FF and GW642444 following single dose of FF/GW642444M Inhalation Powder; determined by measuring the amount of the dose of inhaled medication that reaches the circulation compared to the medication administered intravenously
大体时间:Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks

次要结果测量

结果测量
大体时间
Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax, and MRT for all treatments. In addition, volume of distribution (V) and plasma clearance (CL) for intravenous administrations and mean absorption time (MAT) for inhaled treatments
大体时间:Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
Number of Participants with clinically significant changes to Vital Signs as a measure of Safety and Tolerability
大体时间:Approximately 9 weeks for each subject
Approximately 9 weeks for each subject
Number of Participants with clinically significant changes to 12-lead ECG Tests as a measure of Safety and Tolerability
大体时间:Approximately 9 weeks for each subject
Approximately 9 weeks for each subject
Number of Participants with clinically significant changes to Clinical Laboratory Tests as a measure of Safety and Tolerability
大体时间:Approximately 9 weeks for each subject
Approximately 9 weeks for each subject
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
大体时间:Approximately 9 weeks for each subject
Approximately 9 weeks for each subject

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年5月17日

初级完成 (实际的)

2010年7月15日

研究完成 (实际的)

2010年7月15日

研究注册日期

首次提交

2010年6月10日

首先提交符合 QC 标准的

2011年2月17日

首次发布 (估计)

2011年2月18日

研究记录更新

最后更新发布 (实际的)

2017年6月12日

上次提交的符合 QC 标准的更新

2017年6月9日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

研究数据/文件

  1. 统计分析计划
    信息标识符:102934
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  2. 个人参与者数据集
    信息标识符:102934
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  3. 数据集规范
    信息标识符:102934
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  4. 带注释的病例报告表
    信息标识符:102934
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  5. 知情同意书
    信息标识符:102934
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  6. 临床研究报告
    信息标识符:102934
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  7. 研究协议
    信息标识符:102934
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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