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GSK1521498 Alcohol Interaction Study

2017年7月18日 更新者:GlaxoSmithKline

A Randomised, Double-Blind, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics and Pharmacodynamics of GSK1521498 in Healthy Subjects

The aim of the study is to assess the safety and tolerability of GSK1521498 in combination with alcohol and to determine the amount of GSK1521498 and alcohol in your blood after you have been given these together. The study will also determine whether GSK1521498 will have an effect on alcohol liking and consumption.

研究概览

地位

完全的

条件

详细说明

The study is to test a new drug which may be used for treating alcohol addiction. The drug works by inhibiting the effects of messenger molecules called opioids. These opioids are naturally produced within the human body, and are involved in controlling how much alcohol we drink and the pleasure we get from drinking alcohol. We believe that GSK1521498 might be effective in the treatment of alcohol addiction because it is well known that drugs working on similar binding sites in the brain reduce the pleasure we get from drinking alcohol. As alcohol can effect the way that a drug is metabolised in the body, The investigators need to determine that it is safe to take GSK1521498 in combination with alcohol. and to determine the amount of GSK1521498 and alcohol in your blood after you have been given these together. The study will also determine whether GSK1521498 will have an effect on alcohol liking and consumption.

研究类型

介入性

注册 (实际的)

1

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

    • Texas
      • Austin、Texas、美国、78744
        • 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

21年 至 55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 21 and 55 years of age inclusive.
  • within 20% normal weight for height and body build.
  • A female subject of child-bearing potential must use one of the contraception methods listed in the protocol prior to the start of the study until at least 14 days after receiving the last dose of study medication.
  • Male subjects must agree to use one of the contraception methods listed in the protocol from the time of the first dose of study medication until at least 5 days after receiving the last dose of study medication.
  • History of regular alcohol consumption within 6 months of study.
  • No recent changes in patterns of alcohol consumption.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • A positive test for HIV, Hep B or Hep C.
  • Current or chronic history of liver disease.
  • Current or chronic history of neurological disorders.
  • Subjects with previous or current psychiatric history.
  • Past history of DSM-IV alcohol dependence or abuse.
  • Binge drinking more than once a week (>5 standard drinks in one session is a binge).
  • Currently trying to quit alcohol.
  • Positive urine screen for amphetamines, barbiturates, cocaine, opiates, cannabinoids or bezodiazepines at screening.
  • Regular consumption of >450mg caffeine per day (an average cup contains about 75mg).
  • Heavy smokers, defined as those who smoke >10 cigarettes a day. Also those who cannot abstain during the admission period.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication.
  • Pregnant or lactating females.
  • QTcB or QTcF >450msec.
  • Participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product.
  • Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.

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:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:GSK1521498 & alcohol
GSK1521498 20 mg and alcohol (0.5g/kg ethanol mixed with orange juice)
GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
实验性的:GSK1521498 & orange juice
GSK1521498 20 mg and orange juice approximately matching alcoholic beverage for volume and colour
GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
实验性的:Placebo & alcohol
Placebo and alcohol (0.5g/kg ethanol mixed with orange juice)
安慰剂
安慰剂比较:Placebo & orange juice
Placebo and orange juice approximately matching alcoholic beverage for volume and colour
安慰剂

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pharmacokinetic interaction
大体时间:GSK1521498 PK sampling; pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48 and 72 hr post-dose.
AUC and Cmax of GSK1521498 and alcohol
GSK1521498 PK sampling; pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48 and 72 hr post-dose.

次要结果测量

结果测量
大体时间
Safety: adverse events, vital signs, ECGs, physician/nurse observations, safety lab tests, mood assessments
大体时间:3 Months
3 Months
Neurological assessments including Purdue Pegboard test
大体时间:3 Months
3 Months

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)

2011年5月13日

初级完成 (实际的)

2011年9月16日

研究完成 (实际的)

2011年9月16日

研究注册日期

首次提交

2011年5月12日

首先提交符合 QC 标准的

2011年6月2日

首次发布 (估计)

2011年6月6日

研究记录更新

最后更新发布 (实际的)

2017年7月21日

上次提交的符合 QC 标准的更新

2017年7月18日

最后验证

2017年7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. 个人参与者数据集
    信息标识符:115256
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  2. 统计分析计划
    信息标识符:115256
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  3. 临床研究报告
    信息标识符:115256
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  4. 数据集规范
    信息标识符:115256
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  5. 带注释的病例报告表
    信息标识符:115256
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  6. 知情同意书
    信息标识符:115256
    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:115256
    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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