A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects
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
- Radioactivity cumulative excretion rate into urine
研究概览
简要总结
To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-303 following oral single dose
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
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male subjects who provided written informed consent to participate in the study
- •Aged 18 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
- •Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:
- •Systolic blood pressure: ≧90 mmHg and ≦139 mmHg, Diastolic blood pressure: ≧40 mmHg and ≦89 mmHg, Pulse rate: ≧40 beats per minute (bpm) and ≦99 bpm, Body temperature: ≧35.0°C and ≦37.4°C
排除标准
- •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 evaluations in the study such as asymptomatic pollinosis and wart are excluded)
- •Received a radioisotope-labeled substance or subject to a large quantity of radiation exposure* within 12 months before the first dose of TAS-
- •* A large quantity of radiation exposure includes continuous X-ray irradiation, computed tomography (CT) scan, gastric barium test, and positron emission tomography (PET) scan, excluding tests with low radiation exposure (e.g., chest, bone, or dental X-ray examination, or X-ray examination before boarding an airplane).
- •Occupationally exposed to radiation within a year before the first dose of TAS-303 (such as operators who are involved in nuclear power or radiation operations).
研究组 & 干预措施
TAS-303, [14C]TAS-303
干预措施: TAS-303, [14C]TAS-303 (Drug)
结局指标
主要结局
Radioactivity cumulative excretion rate into urine
时间窗: Day 1 to Day 22
Area under the plasma concentration versus time curve (AUC).
时间窗: Day1 to 8 and 10,12,14,16,18,20,22
Radioactivity cumulative excretion rate into feces.
时间窗: Day 1 to Day 22
Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).
时间窗: Day 1 to Day 22
Concentrations of total radioactivity in blood and plasma
时间窗: Day1 to 8 and 10,12,14,16,18,20,22
Plasma TAS-303 concentrations
时间窗: Day1 to 8 and 10,12,14,16,18,20,22
Maximum plasma concentration (Cmax)
时间窗: Day1 to 8 and 10,12,14,16,18,20,22
Elimination half life (T1/2)
时间窗: Day1 to 8 and 10,12,14,16,18,20,22
次要结局
- Adverse events(Day 1 to Day 29)
- Blood Pressure(Screening period and Day 1, 2, 8, 15, 22, 29)
- Heart rate(Screening period and Day 1, 8, 15, 22, 29)
- QTc interval(Screening period and Day 1, 8, 15, 22, 29)
- Treatment-related adverse events(Day 1 to Day 29)
- Number of Participants With Abnormal Laboratory Values(Screening period and Day -2, 8, 15, 22, 29)
- Pulse rate(Screening period and Day 1, 8, 15, 22, 29)
- Temperature(Screening period and Day 1, 2, 8, 15, 22, 29)