NCT00812643已完成1 期
An Open, Single Centre Pharmacokinetic (Phase 1) Study of the Biliary Excretion of AZD0837 and Metabolites Following a Single Dose of [3H] AZD0837 Given in the Duodenum Via a Loc-I-Gut Catheter to Young Healthy Male Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- The amounts of total radioactivity excreted in bile. Metabolic profile of AZD0837 excreted in bile and identification of previously unknown metabolites and the amounts of AZD0837, AR-H069927XX and AR-H067637XX in bile.
研究概览
简要总结
This is an explorative study and the scientific question to be investigated in this study is if AZD0837 and/or its metabolites AR-H069927XX and AR-H067637XX and other unknown metabolites are excreted into the bile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive
排除标准
- •Significant illness, trauma or surgical procedures.
- •Clinically significant laboratory abnormalities.
- •Clinically significant medical history.
结局指标
主要结局
The amounts of total radioactivity excreted in bile. Metabolic profile of AZD0837 excreted in bile and identification of previously unknown metabolites and the amounts of AZD0837, AR-H069927XX and AR-H067637XX in bile.
时间窗: Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.
次要结局
- PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.(Frequent sampling during 24 hours.)
- Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography.(Some of the safety variables will be followed at each visit, some less frequent.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male VolunteersHealthyRSV InfectionNCT01875926Ablynx, a Sanofi company44
已完成
1 期
Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)Type II Diabetes MellitusNCT00960791AstraZeneca6
已完成
1 期
A Study to Evaluate the Pharmacokinetics of Oral Formulations of MMV390048 Administered Fasted to Healthy VolunteersMalariaNCT02554799Medicines for Malaria Venture18
已完成
1 期
Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male VolunteersHealthyNCT01588626AstraZeneca12
已完成
2 期
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder CancerTransitional Cell Bladder CancerUrethra CancerUreter CancerRenal Pelvis CancerBladder CancerNCT00661609AstraZeneca54