JPRN-jRCT2071230028已完成1 期
A phase 1 open-label study evaluating the effects of food on TAS-205 in healthy volunteers
Takeda Shin'ichi0 个研究点目标入组 20 人开始时间: 2023年6月25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
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 40age old（—）
- 性别
- Male
入选标准
- •(1) Healthy adult male subjects who provided written informed consent to participate in the study
- •(2) Aged 18 years or older and younger than 40 years at the time of informed consent
- •(3) Body weight of 60 kg or more and body mass index of 18.5 or more and less than 25.0 at the time of screening tests
- •(4) Capable of oral intake.
排除标准
- •(1) Had current or previous hypersensitivity or allergy to drugs
- •(2) Had current or previous drug abuse (including use of illicit drugs) or alcoholism
- •(3) Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)
- •(4) Consumed foods or beverages containing pomegranate, pomelo, star fruit, or vegetables of the family mustard (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) within 7 days before study drug administration
- •(5) Consumed foods or beverages containing grapefruit or bitter orange within 14 days before study drug administration
- •(6) Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
- •(7) Consumed fruit juices other than 4), 5), and 6) within 72 hours before study drug administration
- •(8) Consumed foods or beverages containing alcohol or caffeine within 72 hours before study drug administration
研究者
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