JPRN-jRCTs031190136已完成1 期
First-in-human study for effectiveness and safety of [18F]MC225 to evaluate p-glycoprotein function
Ishii Kenji0 个研究点目标入组 9 人开始时间: 2019年11月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
As a result of initial clinical evaluation of 8 healthy males, [18F] MC225 was pharmacologically safe at a dose that can be imaged with PET, and the radiation exposure dose was within the allowable range.
研究设计
- 研究类型
- Other
入排标准
- 年龄范围
- >= 20age old 至 <= 60age old（—）
- 性别
- Male
入选标准
- •The following criteria must be met by ALL Subjects:
- •1. Male subjects aged between 20 and 60 years at the informed consent
- •2. Subjects who provide written informed consent.
排除标准
- •Subjects who have any of the following present or past history of illness:
- •1. Past history of neuropsychiatric disorders such as epilepsy, major depression, or schizophrenia
- •2. Subjects who are currently taking prescription drugs, general pharmaceuticals, quasi-drugs, and health food products (suppliments)
- •3. Smorkers
- •4. Subjects who drink alcohol the day before or the day of the visit
- •5. Subjects who have contraindication of or being inadicuate for MRI
- •6. Subjects who have past history of severe drug hypersensitivity
- •7. Subjects who have past history of cardiovascular diseases
- •8. Subjects who are currently suffering from chronic anemia, chronic renal failure, or any other significant diseases
- •9. Subjects who are judged as ineligible for the study by the principal investigator
研究者
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