NCT04825431已完成1 期
A Phase 1 Open-label Study Evaluating the Pharmacokinetics and Mass Balance of [14C] TAS-205 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205
研究概览
简要总结
To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-205 following oral single doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male who provided written informed consent to participate in the study
- •Aged 20 years or older and younger than 40 years at the time of informed consent
- •Capable of oral intake.
- •Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0
- •Key Exclusion Criteria
- •Had current or previous hypersensitivity or allergy to drugs
- •Had current or previous drug abuse (including use of illicit drugs) or alcoholism
- •Had any concurrent disease (including symptoms and signs; however, diseases that do not affect valuations in the study such as asymptomatic pollinosis and wart are excluded)
- •Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
- •Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:
- •Systolic blood pressure: <90 mmHg or ≥140 mmHg, Diastolic blood pressure: <40 mmHg or ≥90 mmHg, Pulse rate: <40 beats per minute (bpm) or ≥100 bp, Body temperature: 35.0°C or ≥37.1°C
排除标准
- 未提供
研究组 & 干预措施
TAS-205, [14C]TAS-205
Experimental
干预措施: TAS-205, [14C]TAS-205 (Drug)
结局指标
主要结局
Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205
时间窗: Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate into urine and feces.
时间窗: Day 1 to Day 8
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).
时间窗: Day 1 to Day 8
Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation.
时间窗: Day 1 to Day 8
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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