NCT01931761已完成1 期
A Phase I, Single-centre, Non-randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-Selumetinib in Healthy Male Volunteers
适应症
干预措施
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
- Concentration of total radioactivity in blood and plasma and percentage of radioactive dose in urine and faeces and total balance
研究概览
简要总结
To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures.
- •Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive.
- •Regular bowel movements (ie, on average production of at least 1 stool per day).
排除标准
- •Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma.
- •Exposure to radiation levels above background exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
- •History or presence of any clinically significant disease or disorder in the opinion of the investigator
- •Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results, vital signs or ECG at baseline in the opinion of the Investigator.
研究组 & 干预措施
[C14] selumetinib 75mg single dose
Experimental
[C14] selumetinib 75mg single dose
干预措施: [C14] selumetinib (oral) (Drug)
结局指标
主要结局
Concentration of total radioactivity in blood and plasma and percentage of radioactive dose 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
次要结局
- Pharmacokinetic parameters of selumetinib(Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.)
- Plasma concentrations of selumetinib(Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days)
- Metabolite profiling and identification in plasma and excreta(Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.)
- Safety(Assessments prior to treatment and after treatment including follow up.)
研究者
研究点 (1)
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