Brain Penetrance of 2-Hydroxybenzylamine in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Brain Penetrance
研究概览
简要总结
The purpose of this study is to confirm that 2-HOBA crosses the blood brain barrier and to compare blood and cerebrospinal fluid levels of 2-HOBA after a single oral dose.
详细描述
Consenting volunteers between 40 and 70 years old with no morbidity, including males, and females who are not pregnant will be recruited for the study. Three volunteers will be enrolled with a reasonable sampling of ethnicities from the Nashville area, and an effort will be made to recruit males and females. The study will be conducted by the Vanderbilt Clinical Research Center (CRC).
Briefly, the three volunteers will be studied at a single dose level. Baseline assessments will be performed, and then each volunteer will be given a single oral dose (550 mg) of 2-HOBA. Ninety minutes after the dose, a lumbar puncture will be performed to obtain cerebrospinal fluid and a blood sample will be collected. 2-HOBA levels will be measured in cerebrospinal fluid and blood samples from this timepoint to assess the ability or orally ingested 2-HOBA to cross the blood brain barrier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The dietary supplement will be delivered to the Clinical Research Center by the Investigational Pharmacy at Vanderbilt University Medical Center.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals between 40 and 70 years old;
- •Men and women who are not pregnant at the time of study; and
- •Not taking any medication 24 hours prior to and during the study.
排除标准
- •Inability to give informed consent;
- •Current use of anticoagulant medications, such as warfarin (Coumadin), dabigatran (Pradaxa), or rivaroxaban (Xarelto), due to high risk of bleeding complications. Volunteers taking aspirin or clopidogrel (Plavix), will not be excluded, but will be asked to get clearance from their prescribing physician before stopping the drug 24 hours prior to the procedure;
- •Need to discontinue any drug that is administered as standard of care treatment;
- •Unwillingness or inability to use approved birth-control methods (pre-menopausal women); and
- •History of lumbar surgery, fibromyalgia, current lower back pain, or scoliosis.
研究组 & 干预措施
2-HOBA
2-Hydroxybenzylamine acetate: 550mg dose
干预措施: 2-HOBA (Dietary Supplement)
结局指标
主要结局
Brain Penetrance
时间窗: 90 minutes
Ratio of 2-HOBA concentration in the cerebrospinal fluid to plasma 2-HOBA concentration after oral administration (ng/mL)
次要结局
未报告次要终点
研究者
John Rathmacher, PhD
Director of Clinical Research
Metabolic Technologies Inc.