A Study to Investigate the Effects of GW876008 on Brain Activation During Emotional Processing in Healthy Subjects.
2010年10月13日 更新者:GlaxoSmithKline
A Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GW876008 and Lorazepam (Comparator) in Healthy Subjects.
Data suggests that imaging activity of the brain can measure the effects of anti-anxiety drugs.
This study will investigate the effect of GW876008 on areas of the brain involved with thinking and emotion
研究概览
研究类型
介入性
注册 (实际的)
26
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
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California
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La Jolla、California、美国、92093
- GSK Investigational Site
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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 50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 males or females aged 18-50 years, inclusive.
- STAI-trait score = or > 40.
- STAI-state score <50th percentile of the normal population distribution.
- Female subjects of non-childbearing.
- Female subjects of childbearing potential must agree to use appropriate contraception.
- Healthy subjects, as determined by a responsible physician
- Body weight ≥ 50 kg (110 lbs), and BMI within the range 19-29.9 kg/m2 inclusive.
- Demonstrates no significant evidence of active disease, physical or mental impairment when assessed by qualified personnel
- Non-smoker (abstinence from smoking for at least 6 months before the start of the study).
- Normal electrocardiogram.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Read, comprehend, and write English at a sufficient level to complete study-related materials.
- Provide a signed and dated written informed consent prior to study participation
Exclusion Criteria:
- As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
- Any history of suicidal attempts or behaviour.
- Any history or current diagnosis of a psychiatric illness.
- Any history of an endocrine disorder including, but not limited to, diabetes or disorders of the hypothalamus, pituitary, adrenal, or thyroid glands, or gonadal disorder or dysfunction of the reproductive organs.
- Abnormal pepsinogen I level at screening.
- Liver Function Tests (LFTs) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT
- Any other clinically significant laboratory abnormality.
- Positive faecal occult blood test.
- Positive pre-study urine drug/alcohol breath screen.
- Positive pre-study HIV 1/2, Hepatitis B surface antigen and positive Hepatitis C antibody result within 3 months of the start of the study.
- Pre-existing or current Helicobactor pylori infection.
- History of alcohol/drug abuse or dependence within 12 months of the study
- Consumption of grapefruit juice or grapefruit within 14 days prior to the first dose of study medication.
- History of peptic ulcer disease.
- Abnormal screening ECG
- History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
- Systolic blood pressure < 90mmHg or >140mmHg; diastolic blood pressure < 60mmHg or > 90mmHg; pulse rate < 40bpm or > 90bpm.
- Participation in a clinical trial with a drug or new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- 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.
- 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 physician responsible, contraindicates their participation.
- History or current diagnosis of acute narrow angle glaucoma.
- Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
- Current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
- Average daily caffeine intake equivalent to > 4 cups of coffee or > 6 cups of tea.
- Subjects who are left handed.
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
研究衡量的是什么?
主要结果指标
结果测量 |
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Differences in brain activation elicited by Matching Emotional Face Expression paradigm following single oral doses of GW876008 and lorazepam on day 1, sessions 1-4
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次要结果测量
结果测量 |
大体时间 |
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临床实验室检查
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GW876008 blood levels
大体时间:pre-dose & post-dose, sessions 1-4
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pre-dose & post-dose, sessions 1-4
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clinical rating scales change after dosing: questionnaires collected
大体时间:pre-dose & up to 6-8 hours post-dose.
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pre-dose & up to 6-8 hours post-dose.
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Safety: 12-lead ECG, vital signs, adverse events, clinical labs
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fMRI BOLD neuroanatomical structure of the emotional brain neurocircuitry and connectivity
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fMRI BOLD Signal characteristics and connectivity
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fMRI BOLD Response in the emotional brain neurocircuitry and occipital cortex.
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ETCo2 in mm Hg, to be recorded for the duration of the scan session and be synchronized with the single fMRI procedure timing
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Visual Analog Scale (VAS) measurements of sleepiness, alertness, calm, tension, and anxiety performed before dosing (baseline), pre-fMRI session, post-fMRI session and just before leaving the facility.
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Association between the anxiety trait (STAI-trait, test battery for neuroticism or liability for Anxiety Disorders) collected at screening and the various pharmacodynamic parameters measured in the various testing conditions.
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GW876008 concentration to determine pharmacokinetic parameters to be collected twice per session,
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Pharmacogenetic (PGx) assessments
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Safety and tolerability of GW876008 to include Vital signs semi-supine; respiratory rate, pulse oximetry and ECG.
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fMRI BOLD ALS signal.
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Heart rate (HR; beats per minute), to be recorded for the whole duration of the scan session and to be synchronized with the single fMRI procedure timing.
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Respiratory rate (RR: inspiration per minute), to be recorded for the duration of scan session and be synchronized with the single fMRI procedure timing. .
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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。
调查人员
- 研究主任:GSK Clinical Trials, MBChB, MFPM、GlaxoSmithKline
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
2007年3月1日
初级完成 (实际的)
2007年12月1日
研究完成 (实际的)
2007年12月1日
研究注册日期
首次提交
2007年1月17日
首先提交符合 QC 标准的
2007年1月18日
首次发布 (估计)
2007年1月19日
研究记录更新
最后更新发布 (估计)
2010年10月15日
上次提交的符合 QC 标准的更新
2010年10月13日
最后验证
2010年10月1日
更多信息
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.