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A Clinical Study to Determine Biomarkers of Response to a Gamma Secretase Inhibitor

2016年6月16日 更新者:Merck Sharp & Dohme LLC

A Randomized Clinical Trial to Study the Effects of MK0752 Versus Placebo on Biomarkers in Healthy Young Adult Male Subjects

The purpose of this study is to determine the transcriptional signature of Notch Inhibition by testing hair and blood samples on healthy male volunteers who have received MK0752 vs placebo for possible future biomarkers in the treatment of cancer or Alzheimers Disease

研究概览

研究类型

介入性

注册 (实际的)

30

阶段

  • 阶段1

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 35年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Patient is a male
  • Patient has no clinically significant abnormality on electrocardiogram performed
  • Patient agrees to not to consume apple juice, grapefruit or grapefruit products beginning 2 weeks prior to first dose of study drug and for the duration of the study
  • Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for approximately 6 months.
  • Patient is willing to not use any hair enhancement product or procedures for the duration of the study (for example, permanents, hair straightening techniques)
  • Patient has a full head of hair
  • Patient has at least 90% non-gray hair

Exclusion Criteria:

  • Patient has had treatment with any investigational therapy during the prior 21 days
  • Patient has any history of significant gastrointestinal abnormalities within the last 10 years
  • Patient has a history of any long-term or active liver disease including elevated liver blood tests. Any patient with a history of Hepatitis B or C (and/or treated previously) will be excluded
  • Patient has a known history or family history of aortic valve disease, congenital (from birth) heart disease or deafness, hearing loss or early onset Alzheimer's disease (onset at age < 55)
  • Patient has a known sensitivity to the ingredients in the drug
  • Patient has had active and uncontrolled infection within the past month
  • Patient is HIV positive
  • Patient has a history of stomach, intestine, heart, blood, liver, brain, kidney, lung, bladder or endocrine abnormalities or diseases
  • Patient has a history of cancer except for certain skin cancer (basal cell)
  • Patient has a history of multiple and/or severe allergies or has had an allergic reaction to food or prescription/non-prescription drugs
  • Patient has had major surgery, donated or lost 1 unit of blood (about 500 mL) within the past month
  • Patient has premature graying hair (> 10% gray hair)
  • Patient has male pattern hair loss
  • Patient has a prior history of high blood pressure
  • Patient uses any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort) beginning approximately 2 weeks prior to the first dose of study drug, throughout the study until the post study visit
  • Patient consumes excessive amounts of alcohol (greater than 3 glasses of alcoholic beverages)
  • Patient consumes excessive amounts (greater than 6 servings) of coffee, tea, cola or other caffeinated beverages per day
  • Patient is a regular use (including "recreational use") of any illicit drugs, has a positive urine drug screen before randomization or has a history of drug (including alcohol) abuse within approximately the past 2 years
  • Patient has prior exposure to MK 0752 with the past 21 days

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:诊断
  • 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
安慰剂比较:C
安慰剂
Single dose placebo capsules: there will be a 7-day washout period between treatments.
有源比较器:A
MK0752 1000 mg
Single dose MK0752 capsules, 1000 mg: there will be a 7-day washout period between treatments.
有源比较器:B
MK0752 350 mg
Single dose MK0752 capsules, 350 mg: there will be a 7-day washout period between treatments.
其他名称:
  • MK0752

研究衡量的是什么?

主要结果指标

结果测量
大体时间
To evaluate the existing Notch response signature using plucked hair follicle profiling data from health young male volunteers given 1000 mg MK0752 and 350 mg MK0752.
大体时间:8.5 hours post dose.
8.5 hours post dose.

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

2008年12月1日

初级完成 (实际的)

2009年1月1日

研究完成 (实际的)

2009年1月1日

研究注册日期

首次提交

2008年12月5日

首先提交符合 QC 标准的

2008年12月5日

首次发布 (估计)

2008年12月8日

研究记录更新

最后更新发布 (估计)

2016年6月17日

上次提交的符合 QC 标准的更新

2016年6月16日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 0752-022
  • 2008_594

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.

MK0752的临床试验

3
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