NCT00711074已完成1 期
An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers
适应症
干预措施
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
- 4
- 试验地点
- 1
- 主要终点
- total radioactivity in plasma, whole blood, faeces and urine.
研究概览
简要总结
The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass index (BMI) 18-30 kg/m2, inclusive.
- •Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology & urinalysis, as judged by the investigator
排除标准
- •Healthy volunteers who have been exposed to radiation levels above background (eg through X-ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
- •Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
- •Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)
研究组 & 干预措施
1
Experimental
干预措施: AZD5672 (Drug)
结局指标
主要结局
total radioactivity in plasma, whole blood, faeces and urine.
时间窗: Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h
Additional metabolite identification
时间窗: 0.5h, 3h, 6h, 12h, 24h
次要结局
- general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs(Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up)
研究者
研究点 (1)
Loading locations...
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