NCT01217645已完成1 期
A Phase I, Open-label, Single-Centre Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration to Healthy Male Subjects
适应症
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
- The change in distribution, metabolism, and elimination of AZD6765 and total radioactivity after single-dose (150 mg) intravenous administration of [14C]-labelled AZD6765
研究概览
简要总结
This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a single-dose intravenous administration.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must have a normal creatinine clearance of ≥60 mL/min
- •Subjects who self-identify their race as Asian
排除标准
- •History of any clinically significant medical, neurologic or psychiatric disease as judged by the investigator
- •History of symptomatic orthostatic hypotension (ie, postural syncope)
- •Subjects who have received any radiolabelled study drug within 12 months of the Screening Visit.
- •Subjects who are monitored for radioactivity as part of their occupation
- •Subjects who have been exposed to radiation levels above background, (eg, throughX-Ray examinations) of >5mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1mSv per year of life.
结局指标
主要结局
The change in distribution, metabolism, and elimination of AZD6765 and total radioactivity after single-dose (150 mg) intravenous administration of [14C]-labelled AZD6765
时间窗: Blood samples will be taken from predose until upto 240 hrs from start of infusion to assess radioactivity
The change in excretion of 14C (mass balance) in urine and faeces after a single intravenous dose of 150 mg [14C] AZD6765
时间窗: Urine and feacal samples will be taken from predose until up to 240 hrs from start of infusion to assess radioactivity
次要结局
- Safety and tolerability after a single IV administration of [14C] AZD6765 by assessing a panel of measures: adverse events, blood pressure and pulse, blood samples, urinalysis, hematology, clinical chem, physical exam, ECG and symptoms of suicidality.(A Range from predose until up to 240 hrs from start of infusion.)
- To identify and profile the metabolites in selected samples of urine, faeces and plasma following a single intravenous dose of 150 mg [14C] AZD6765(A Range from predose until up to 240 hrs from start of infusion.)
研究者
研究点 (1)
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