Pharmacokinetic Evaluation of Intravenous Ascorbic Acid
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- identify the maximum tolerated dose (MTD)
研究概览
简要总结
This Phase I study will be conducted in 2 parts to examine safety and pharmacokinetics of escalating doses of intravenous ascorbic acid (AA) first in healthy volunteers followed by evaluation in oncology subjects. The study will be conducted in the Program in Integrative Medicine Infusion Clinic at the University of Kansas Medical Center in conjunction with the Program in Integrative Medicine, Kansas Cancer Research Institute, Department of Pharmacy, Department of Medical Oncology, the Division of Surgical Oncology,and with consultants from the NIH, and FDA.
详细描述
The purpose of this study is to examine what happens when Vitamin C enters into the body, and the speed and ways it travels through the body, and the rate at which it exits the body in the urine. It is also necessary to determine if it is safe to give Intravenous Vitamin C at high doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phase I, IV Vitamin C Healthy Normals
Safety and pharmacokinetics of intravenous ascorbate,IV Vitamin C.
干预措施: IV Vitamin C (Drug)
Phase 1 IV Vitamin C- Cancer Patients
Safety and pharmacokinetics of intravenous ascorbate,IV Vitamin C.
干预措施: IV Vitamin C (Drug)
结局指标
主要结局
identify the maximum tolerated dose (MTD)
时间窗: Change from infusion to 24 hours past infusion
This will be accomplished by obtaining the following evaluations: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, ECG, basic metabolic panel, bicarbonate (pH surrogate marker), CBC, and osmolality.
次要结局
- measure how the body absorbs, distributes and excretes intravenous ascorbic acid(0,.5,1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 24 hours post-dose)
- measure the biochemical and physiological effects of intravenous ascorbic(0,.5,1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 24 hours post-dose)
研究者
Jeanne Drisko, MD, CNS, FACN
Riordan Endowed Professor of Orthomolecular Medicine
University of Kansas Medical Center