Glyburide Healthy Volunteer Study
研究概览
详细说明
This study is a placebo controlled (2:1 drug vs. placebo), randomized clinical trial of 21 healthy, non-diabetic volunteers receiving daily doses of oral glyburide (1.5 mg) vs. placebo while under careful medical monitoring in an inpatient Clinical Research Unit (CRU)within the Center for Applied Research Sciences (CARS) at the Washington University in St. Louis Medical Center for a duration of 7 days and nights (24 hours per day). Interested subjects who call for more information about the study will be scheduled for a screening visit. Subjects will participate first in an informed consent process, and those wishing to take part will be asked to undergo a comprehensive interview detailing their past medical history and formal physical examination (which includes laboratory tests of the urine and blood). If a subject is deemed appropriate by the team, he/she will be asked to perform an exercise test (treadmill for 30 minutes) and will have an Electrocardiogram (ECG) completed to further determine eligibility. Individuals who do not meet inclusion criteria based on screening activities will be notified immediately that they are not eligible. Volunteers meeting all eligibility criteria will be scheduled for the week long in-patient evaluation.
Each subject will undergo a battery of physical, cognitive, and laboratory tests in addition to receiving oral glyburide or placebo each day for one week.
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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Missouri
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St. Louis、Missouri、美国、63110
- Washington University in St. Louis Clinical Research Unit (CRU)
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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:
- Volunteers between the ages of 18 and 40.
- Have a Body Mass Index (BMI) between 18-30.
- Normal screening physical examination (non-pregnant as confirmed by serum Beta HcG,non-diabetic as confirmed by normal Hgb A-1C, normal baseline ECG and vital signs, laboratory values within normal limits (the lab tests include: complete blood count, electrolytes, liver function tests, kidney function tests, uric acid, cholesterol, iron, urinalysis, urine drug screen; all are conducted within 2 weeks prior to randomization).
- Women of Childbearing Potential (WCP) demonstrate a willingness to use contraception methods (other than birth control medications) to prevent pregnancy from time of consent to 30 days past last dose. **Note, birth control medications MAY BE used after completion of the inpatient hospital phase of the study (i.e. after discharge).
- Unremarkable past medical history.
- Ability to provide informed consent.
- Ability to undergo physical exercise (determined through a treadmill exercise test to ensure physical fitness of participants). Those who experience fatigue, dizziness or chest pain during the screening exercise test on the treadmill will be excluded.
- Ability to undergo neuropsychological test for attention, cognition, dexterity, etc.
- Willing to remain in the in-patient setting for the duration of the study.
Exclusion Criteria:
- Use of investigational drug within 4 weeks of study.
- Using tobacco.
- Acute illness or surgery within 4 weeks of study.
- Allergic to sulfonylurea-related drugs.
- Presence of pathological condition of any part of the body.
- Any medication within 2 weeks of the study, including oral contraceptives.
- Ingestion of alcohol or caffeine containing food or beverages within 48 hours of start of study.
- History of alcohol or drug abuse, cardiac arrhythmias, psychotropic agent use, immunosuppressive condition (i.e. HIV, AIDS, Cancer) or hepatitis.
- Donation of blood within 3 months or receiving blood products within 14 days.
- Recent body tattoo or piercing.
学习计划
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：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Glyburide
1.5 mg (lowest dose) by mouth every day with breakfast for 7 days
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其他名称：
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安慰剂比较：Sugar Pill (Capsule)
Matching placebo capsule by mouth every day with breakfast for 7 days
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其他名称：
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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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Number of Participants with Adverse Events
大体时间：7 days
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The primary objective of this study is to evaluate the safety of glyburide in healthy, non-diabetic volunteers while simulating strenuous activity to observe for any adverse events (i.e.
hypoglycemia, dizziness, confusion, etc.).
Neuropsychological testing, physical exams, vital signs, ECGs, cognitive assessments, and laboratory values (including serum glucose levels collected 4 x's per day and as needed) will be conducted throughout the 7 day in-patient study to assess for any adverse/serious adverse events.
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7 days
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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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Cognitive impact
大体时间：7 days
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Determine the impact after 7 days of glyburide 1.5mg daily (with breakfast) in healthy volunteers who are able to participate in scheduled strenuous activities and adhere to a structured meal plan on cognitive performance using a computer program to test cognition before study drug administration and at the end of the study in addition to daily physical examinations which include mini mental status exams.
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7 days
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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
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