NCT02881840已完成1 期
An Open Label, Single Dose, Single Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] APD421 Administered Via the Intravenous Route to Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mass Balance
研究概览
简要总结
Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 males
- •Age 18 to 65 years of age at time of signing informed consent
- •Body mass index (BMI) of 18 to 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- •Must be willing and able to communicate and participate in the whole study
- •Must provide written informed consent
- •Must agree to use an adequate method of contraception (as defined in Section 8.4)
- •Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
排除标准
- •Prior participation in another study with a radiation burden of > 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of > 1 mSv and ≤ 2 mSv in the period of 2 years prior to screening; a radiation burden of > 2 mSv and ≤ 3 mSv in the period of 3 years prior to screening, etc (add 1 year per 1 mSv)
研究组 & 干预措施
14C-APD421
Experimental
干预措施: 14C-APD421 (Drug)
结局指标
主要结局
Mass Balance
时间窗: 168 hours
Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421
次要结局
未报告次要终点
研究者
研究点 (1)
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