2-Hydroxybenzylamine: Multiple Dosing Study in Healthy Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Multiple Dose Tolerability
研究概览
简要总结
The purpose of this study is to test how well people tolerate a new dietary ingredient called 2-HOBA and how it is metabolized in the body. 2-HOBA is a compound that occurs naturally in buckwheat seeds. This dietary ingredient has been used in animal studies, and single doses have been tolerated well when given to a small group of healthy people. In this study we will test how well people tolerate taking 2-HOBA over 2 weeks and how it is metabolized by the body.
详细描述
Consenting healthy volunteers between 18 and 59 years old with no morbidity, including males, and females who are not pregnant will be recruited for the study. Eighteen volunteers will be studied with a reasonable sampling of ethnicities from the Nashville area, and an effort will be made to recruit equal numbers of males and females. The study will be conducted by the Vanderbilt Clinical Research Center (CRC).
Based upon single dose pharmacokinetics, two multiple dose regimens will be studied to determine the safety, accumulation kinetics, and pharmacodynamic effects of multiple daily doses administered over 2 weeks. A complete health history and physical examination will be conducted by a physician. An EKG, baseline blood and urine sample, and vital signs will be taken prior to supplement administration. A physician will oversee all clinical aspects of the study and will be responsible for all trial-related medical decisions. Additionally, DNA will be collected from the blood drawn and used to determine if there are any genetic differences in metabolism of 2-HOBA. Volunteers will be given 3 daily doses of either placebo or one of two levels of 2-HOBA to determine the safety, accumulation kinetics, and pharmacodynamic effects of the multiple dose administration over a 2 week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The dietary supplement will be delivered to the Clinical Research Center by the Investigational Pharmacy at Vanderbilt University Medical Center. Staff nurses and participants will be blinded to the capsule content.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals between 18 and 59 years old;
- •Men and women who are not pregnant at the time of study; and
- •Not taking any medication 2 weeks prior to or during the study.
排除标准
- •Inability to give informed consent;
- •Diseases that could manifest symptoms or signs that would confound interpretation of the relationship between 2-HOBA action and potential adverse effects;
- •Diseases that could manifest morbidity;
- •Known cardiac disease, kidney disease, or hepatic dysfunction;
- •Need to discontinue any drug that is administered as standard of care treatment; and
- •Unwillingness or inability to use approved birth-control methods.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
2-HOBA High Dose
2-Hydroxybenzylamine acetate: 750mg dose
干预措施: 2-HOBA (Dietary Supplement)
2-HOBA Low Dose
2-Hydroxybenzylamine acetate: 500mg dose
干预措施: 2-HOBA (Dietary Supplement)
结局指标
主要结局
Multiple Dose Tolerability
时间窗: 15 Days
Tolerability will be assessed through adverse event reporting compared with the placebo group (Comparison of number of AE in treated group to number of AE in placebo group).
次要结局
- Measurement of oxidative protein adducts in platelets(15 Days)
- Blood Pressure(15 Days)
- Maximum Plasma Concentration (Cmax)(Day 1 and Day 15)
- Area Under the Curve (AUC)(Day 1 and Day 15)
研究者
John Rathmacher, PhD
Director of Clinical Research
Metabolic Technologies Inc.