NCT01284595已完成1 期
[14C] AZD8931 - A Phase I, Open Label Study of the Absorption, Metabolism, Excretion, and Pharmacokinetics Following a Single Oral Dose to Healthy Male Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects
研究概览
简要总结
Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose Oral Administration
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index (BMI) of ≥19 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
- •Regular daily bowel movements (ie, production of at least 1 stool per day).
- •Non-smokers or ex-smokers who have stopped smoking for >3 months before Visit 1 and have not used nicotine products for >3 months
- •Healthy Male volunteers aged 50 to 65 years, inclusive
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 in the last 5 years, or a cumulative total of >1 mSv per year of life
- •Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1).
- •History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)
研究组 & 干预措施
AZD8931
Experimental
[14C] AZD8931
干预措施: [14C] AZD8931 (Drug)
结局指标
主要结局
To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects
时间窗: Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose
To investigate the pharmacokinetic variable of AZD8931 in plasma
时间窗: Multiple PK blood samples from pre-dose until 240 hours post last dose
次要结局
- To investigate the safety and tolerability of AZD8931 given orally(Frequent safety measurements during the study from screening period to follow-up)
- To investigate the AZD8931 metabolites variables in plasma(Multiple PK blood samples from pre-dose until 240 hours post last dose)
研究者
研究点 (1)
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