A Phase I, Single-centre, Non-Randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of radioactive dose recovered in urine and faeces and total percentage
研究概览
简要总结
This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C]-AZD4205.
详细描述
Phase I study to evaluate the excretion of AZD4205 radioactive dose, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]-AZD4205 in healthy male volunteers. The purpose of this study is to investigate ADME properties of AZD4205 by analyzing blood, urine and feces collected during the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 18 to 65, who must be willing to use reliable methods of contraception, even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil.
- •In addition, subjects must agree to continue to take similar contraceptive precautions until 6 months after administration of AZD4205 and avoid procreative sex as well as sperm donation for 6 months after administration of AZD4205.
排除标准
- •Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at screening or baseline in the opinion of the investigator.
- •Subjects who may have been exposed to radiation for therapeutic or diagnostic reasons at levels above background (e.g,, through X-ray examination other than dental X-rays or plain X-rays of thorax or bony skeleton) of > 5 mSv in last year, > 10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life.
研究组 & 干预措施
[14C]-AZD4205
A single dose of [14C]-AZD4205
干预措施: [14C]-AZD4205, single 50 mg oral dose administrated on day 1 (Drug)
结局指标
主要结局
Percentage of radioactive dose recovered in urine and faeces and total percentage
时间窗: Up to 57 days
To evaluate the percentage of radioactive dose of \[14C\] radiolabelled AZD4205 recovered in urine, feces, and in total
Provide samples for subsequent studies
时间窗: Up to 57 days
Provide samples for subsequent studies to characterize the metabolism of \[14C\]AZD4205
次要结局
- AUC(0-t) for [14C] radioactivity in plasma and whole blood(Up to 57 days)
- tmax for [14C] radioactivity in plasma and whole blood(Up to 57 days)
- tlag for [14C] radioactivity in plasma and whole blood(Up to 57 days)
- Distribution of total radioactivity in blood(Up to 57 days)
- AUC(0-inf) for [14C] radioactivity in plasma and whole blood(Up to 57 days)
- Cmax for [14C] radioactivity in plasma and whole blood(Up to 57 days)
- t1/2 for [14C] radioactivity in plasma and whole blood(Up to 57 days)
- λz for [14C] radioactivity in plasma and whole blood(Up to 57 days)
- CL/F for [14C] radioactivity in plasma and whole blood(Up to 57 days)
- Vss/F for [14C] radioactivity in plasma and whole blood(Up to 57 days)