NCT02434835已完成1 期
Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 主要终点
- Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites
研究概览
简要总结
The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of [14C]KWA-0711 to healthy male subjects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.
- •Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
- •Subjects who have a body weight between 50 and 100 kg, inclusive.
- •Subjects must have regular bowel movements.
排除标准
- •Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.
- •Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.
- •Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.
- •Subjects who have any clinically significant abnormal laboratory safety findings.
- •Subjects who have had an X ray or who have participated in any clinical trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.
研究组 & 干预措施
[14C]KWA-0711
Experimental
干预措施: [14C]KWA-0711 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites
时间窗: 240 hours
Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites
时间窗: 240 hours
Cumulative radioactivity recovery in urine and feces
时间窗: 240 hours
Profiles of metabolites in plasma, urine and faeces
时间窗: 240 hours
次要结局
- Number of adverse events(240 hours)
研究者
相似试验
已完成
1 期
Human Mass Balance and Biotransformation Study of [14C]TNP-2198Helicobacter Pylori InfectionNCT06137573TenNor Therapeutics (Suzhou) Limited6
已完成
1 期
AME Study of [14C]-YH4808 in Healthy Male SubjectsHealthyNCT01825707Yuhan Corporation8
已完成
1 期
TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male SubjectsChronic Obstructive Pulmonary Disease (COPD)NCT02772159Mylan Inc.9
已完成
1 期
A Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-JNJ-42847922 After a Single Oral Dose of 40 mg in Healthy SubjectsHealthyNCT03025022Janssen Research & Development, LLC8
已完成
不适用
Absorption, Metabolism and Excretion of Dietary Polyphenolic Bioactives in HumansHealthyNCT03194620University of California, Davis12