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The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers

2014年10月14日 更新者:Janssen Research & Development, LLC

The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Subjects

The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating anxiety disorders through evaluation of brain activation patterns using imaging technology in healthy volunteers.

研究概览

地位

完全的

条件

详细说明

This is a single site, double-blind (neither investigator nor the participant knows the treatment that the participant receives) study. The study will consist of a screening phase (1-2 visits), a treatment phase (4 visits), and a post treatment phase (follow-up safety visit, 7 to 14 days after the last dose of the study drug). During the screening phase, participants will be evaluated to determine if they meet the study eligibility criteria, which will include collection of blood and urine samples. During the treatment phase, eligible participants will be assigned by chance (like a toss of a coin) to receive either JNJ-42165279 100 mg or placebo once daily during 4 consecutive visits to the clinic. Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. The potential of the drug to treat anxiety will be assessed on Day 4 of the treatment phase. The primary assessment, Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI), will measure brain activity patterns while participants complete 3 emotionally-provoking tasks. Additionally, participants' startle responses (eye blinks) will be evaluated in two emotionally-provoking behavioral tasks outside of the scanner. Questionnaires will be completed to evaluate participants' mood, and blood samples will be collected to measure concentrations of JNJ-42165279 and biomarkers of drug activity.

Safety will be monitored throughout the study, including adverse events, vital signs (blood pressure and heart rate), 12-lead ECGs, physical examinations, clinical safety laboratories, evaluation of suicidal risk, and a Walk and Turn test. The total study duration will be approximately 46 days.

研究类型

介入性

注册 (实际的)

43

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

    • California
      • La Jolla、California、美国

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 45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

  • Good general health
  • Body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg
  • Must adhere to required contraception during and for 3 months after study
  • Must agree to not donate sperm during and for 3 months after study
  • Must agree to not donate blood during and for 1 month after study
  • Able to speak and understand English fluently

Exclusion criteria:

  • Clinically significant medical or psychiatric illness
  • Any contraindication to magnetic resonance imaging
  • Unable to pass hearing test
  • Alcohol or substance abuse; excessive nicotine or caffeine use
  • Recently received an investigational drug, vaccine, or invasive medical device
  • Unable to abide by protocol restrictions on use of other medications

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:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:安慰剂
Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.
实验性的:JNJ-42165279 (100 mg)
JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.

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
Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior)
大体时间:Day 4
BOLD-fMRI percent signal changes during an Emotional Face Processing task.
Day 4

次要结果测量

结果测量
措施说明
大体时间
Brain activity patterns in multiple areas of the emotional brain neurocircuitry
大体时间:Day 4
BOLD-fMRI percent signal changes during emotionally-provoking tasks (pictures of emotional faces, periods of breathing restriction, presentations of a loud noise).
Day 4
Startle response
大体时间:Day 4
Eye blink responses to a loud noise during 2 emotionally-provoking tasks outside of the MRI scanner.
Day 4
The number of volunteers who experience adverse events as a measure of safety and tolerability.
大体时间:Day -28 to Day 18
Day -28 to Day 18

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。

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

2013年8月1日

初级完成 (实际的)

2014年8月1日

研究完成 (实际的)

2014年8月1日

研究注册日期

首次提交

2013年4月4日

首先提交符合 QC 标准的

2013年4月4日

首次发布 (估计)

2013年4月9日

研究记录更新

最后更新发布 (估计)

2014年10月15日

上次提交的符合 QC 标准的更新

2014年10月14日

最后验证

2014年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • CR100975
  • 42165279ANX1001 (其他标识符:Janssen Research & Development, LLC)

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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