NCT00829088已完成1 期
An Open Label, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD2066 to 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
- 6
- 试验地点
- 1
- 主要终点
- Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066
研究概览
简要总结
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.
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
- 35 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed informed consent
- •Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.
排除标准
- •History of somatic disease/condition, which may interfere with the objectives of the study.
- •History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
- •Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examinations).
结局指标
主要结局
Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066
时间窗: Until >90% of predicted total radioactivity has been recovered
Pharmacokinetics of total radioactivity in plasma and unchanged AZD2066 in plasma
时间窗: Sampling at defined timepoints during residential period from pre-dose until 168h post-dose.
Metabolite profile in plasma and excreta
时间窗: Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.
次要结局
- AZD2066 metabolites in plasma+excreta if feasable(Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.)
- Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables, ECG and adverse events(Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period) and follow up visit 3.)
研究者
研究点 (1)
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