An Open-Label, Single-Centre, Phase I Study to Assess the Excretion, Metabolism and Plasma Pharmacokinetics Following a Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers
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
- Percentage of radioactive dose recovered in urine and faeces and total balance
研究概览
简要总结
The purpose of the study is to characterise the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD9668.
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
- •Provision of signed, written and dated informed consent prior to any study specific procedure
- •Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
排除标准
- •Exposed to radiation levels above background 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
- •History or presence of any clinically significant disease or disorder in the opinion of the investigator
- •Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
研究组 & 干预措施
1
[C14]AZD9668
干预措施: [C14]AZD9668 (Drug)
结局指标
主要结局
Percentage of radioactive dose recovered in urine and faeces and total balance
时间窗: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Concentration of total radioactivity in blood and plasma
时间窗: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Plasma concentrations of AZD9668
时间窗: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Metabolite profiling and identification in plasma and excreta
时间窗: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
PK of AZD9668 (Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR )
时间窗: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
次要结局
- Adverse Events(Adverse events collected prior to treatment and after treatment including follow up.)