Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Pharmacokinetics (Cmax: Maximum plasma concentration)
研究概览
简要总结
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy adult subjects
- •Body mass index: >=18.5 and <25.0
排除标准
- •Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
- •Have participated in a [14C]-study within the last 12 months prior to dosing of the investigational drug
- •Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug
- •Occupationally exposed worker
研究组 & 干预措施
14C-FYU-981
14C-FYU-981, (Oral single dosing)
干预措施: 14C-FYU-981 (Drug)
结局指标
主要结局
Pharmacokinetics (Cmax: Maximum plasma concentration)
时间窗: 168 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
时间窗: 168 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
时间窗: 168 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
时间窗: 168 hours
Pharmacokinetics (kel: Elimination rate constant)
时间窗: 168 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed
时间窗: 168 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
时间窗: 168 hours
Pharmacokinetics (MRT: Mean residence time)
时间窗: 168 hours
Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air)
时间窗: 168 hours or 72 hours (Ae(air))
Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air)
时间窗: 168 hours or 72 hours (Ae(air))
Pharmacokinetics (Ae(total): Total amount of radioactivity excreted)
时间窗: 168 hours
Pharmacokinetics (fe(total): Total fraction of radioactivity excreted)
时间窗: 168 hours
Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air)
时间窗: 168 hours
Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air)
时间窗: 168 hours
Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces)
时间窗: 168 hours
次要结局
未报告次要终点