A Phase 1, Open-Label, Non-randomized, Single-Center Study to Assess Distribution, Metabolism and Excretion After [14C]-Labelled Intravenous Administration of AZD9742 as a 2-hour Infusion to Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 试验地点
- 1
- 主要终点
- To characterize the distribution and elimination of AZD9742 and total 14C radioactivity in healthy volunteers following a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion.
研究概览
简要总结
The purpose of this study is to assess distribution, metabolism, and excretion of radio-labelled AZD9742 administered as a 2-hour infusion to healthy male volunteers.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers age 55 years or older on Day 1, body weight >50 kg, body mass index (BMI) between 18 kg/m2 and 30 kg/m2
- •Regular bowel movements, at least once per day (self reported)
- •Volunteers must be willing to have intravenous (IV) and blood sampling from either arm.
- •Volunteers should ensure that their partners of child-bearing potential use a reliable method of contraception, as well as using a barrier method themselves.
排除标准
- •History of any clinically significant disease or abnormalities, including history or presence of gastrointestinal, hepatic, renal disease or any other condition known to interfere with metabolism, or excretion of drugs
- •Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
- •Current smokers or those who have smoked or used nicotine products within the previous 30 days
- •History of alcohol abuse or excessive intake of alcohol
- •Participation in more than 1 other radiolabeled investigational study drug trial within 1 year prior to check-in. The previous radiolabeled study drug had to be received more than 6 months prior to check-in and the total exposure from this study and the previous study must be within the CFR recommended levels considered safe (per 21 CRF 362.1, less than 5,000 mrem whole body annual exposure).
研究组 & 干预措施
A
[14C]-AZD9742 1000 mg intravenous over 2 hours
干预措施: [14C]-AZD9742 (Drug)
结局指标
主要结局
To characterize the distribution and elimination of AZD9742 and total 14C radioactivity in healthy volunteers following a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion.
时间窗: Range of 12 hours pre dose to 168 hours post dose
12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first.
To evaluate the excretion of 14C (mass balance) in urine and feces after a single 1000 mg intravenous (IV) dose of [14C]-AZD9742 administered as a 2-hour infusion.
时间窗: Range of 12 hours pre dose to 168 hours post dose
12 hours pre dose to 168 hours post dose of the treatment period if the patient meets discharge criteria. If the patient does not meet discharge criteria after 168 hours post dose, additional 24 hour collections up to 7 additional days or until discharge criteria are met, whichever occurs first.
次要结局
- Safety of AZD9742 after a single intravenous 14C administration of AZD9742, by assessing a panel of measures: Adverse Events, vital sign evaluations, physical examination, electrocardiograms (ECG) and clinical laboratory parameters.
- To explore and establish the metabolite profiles in plasma and excreta; where possible the identity of metabolites will be determined.(Immediately prior to the end of the infusion, 4 hours after the end of the infusion and 24 hours after the start of the infusion.)