jRCT2071230061已完成不适用
A Mass Balance Study of [14C] TAS5315 in Healthy Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Plasma and blood radioactivity concentrations
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 40age old not（—）
- 性别
- Male
入选标准
- •Aged 18 or older and younger than 40 years at the time of consent
- •Weigh at least 45.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height {m}]2) ranging from 18.0 to < 25.0 kg/m2
- •Blood pressure and body temperature obtained in screening tests within the following ranges
- •a Systolic blood pressure (in supine position), 90 to 139 mmHg
- •b Diastolic blood pressure (in supine position), 40 to 89 mmHg
- •c Body temperature ranging from 35.0 to 37.4
- •Judged to be healthy by the investigator based on the examination findings (subjective symptoms and objective findings), blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests (hematology test, biochemistry test, and urinalysis) at the time of screening tests
排除标准
- •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)
- •Had any severe disease history that may recur during the study period.
结局指标
主要结局
Plasma and blood radioactivity concentrations
Plasma TAS5315 concentrations and their pharmacokinetic parameters, and blood/plasma radioactivity concentration ratio
Excretion and rate of radioactivity in urine and feces
Cumulative excretion and cumulative excretion rate
Total amount and rate of excretion of radioactivity in urine and feces
Total amount and rate of cumulative excretion
Metabolite profile and structural estimation of TAS5315
Metabolite profile and structural estimation of TAS5315 in plasma, urine and feces
次要结局
未报告次要终点
研究者
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