The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers
The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Subjects
研究概览
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
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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California
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La Jolla、California、美国
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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安慰剂比较:安慰剂
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Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.
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实验性的:JNJ-42165279 (100 mg)
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JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.
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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 |
|---|---|---|
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Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior)
大体时间:Day 4
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BOLD-fMRI percent signal changes during an Emotional Face Processing task.
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Day 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Brain activity patterns in multiple areas of the emotional brain neurocircuitry
大体时间:Day 4
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BOLD-fMRI percent signal changes during emotionally-provoking tasks (pictures of emotional faces, periods of breathing restriction, presentations of a loud noise).
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Day 4
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Startle response
大体时间:Day 4
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Eye blink responses to a loud noise during 2 emotionally-provoking tasks outside of the MRI scanner.
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Day 4
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The number of volunteers who experience adverse events as a measure of safety and tolerability.
大体时间:Day -28 to Day 18
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Day -28 to Day 18
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CR100975
- 42165279ANX1001 (其他标识符:Janssen Research & Development, LLC)
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