jRCT2071220057已完成不适用
A phase I open-label study to investigate the absorption, metabolism and excretion of [14C]KDT-3594 following single oral administration in healthy adult male subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Urinary radioactivity excretion
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 45age old under（—）
- 性别
- Male
入选标准
- •Healthy Japanese male
- •Age: >18 to =<45 years old
- •BMI: >=18.5 to <25.0 kg/m2
- •Body weight: >=50 kg
排除标准
- •Subjects with complication or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, (including alcoholic liver disease, non-alcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver disease), psychiatric, neurological, or allergic disease (including drug allergy, but excluding untreated, asymptomatic or seasonal allergy at the time of administration)
结局指标
主要结局
Urinary radioactivity excretion
放射性物质在尿液中的排泄量
Urinary radioactivity excretion rate
放射性物质在尿液中的排泄速率
Fecal radioactivity excretion
放射性物质在粪便中的排泄量
Fecal radioactivity excretion rate
放射性物质在粪便中的排泄速率
Cumulative excretion
放射性物质的累积排泄量
Cumulative excretion rate
放射性物质的累积排泄速率
Recovery
放射性物质的回收量
Recovery rate
放射性物质的回收速率
Total recovery
放射性物质的总回收量
Total recovery rate
放射性物质的总回收速率
次要结局
- Radioactivity concentration in whole blood and plasma
- Concentration of unchanged drug and main metabolites in plasma
- Metabolite profiling and structural estimation of metabolites in plasma, urine and feces
- Incidence of adverse events and adverse drug reactions
- Laboratory tests, vital signs, body weight, 12-lead ECG
研究者
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