A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
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
- Collection of plasma, urine and fecal samples for structural identification
研究概览
简要总结
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Must provide written informed consent
- •Body mass index (BMI) 18.0 to 30.0 kg/m2 as measured at screening
- •Weight ≥50 kg and ≤100 kg inclusive at screening
- •Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
排除标准
- •Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- •Evidence of current SARS-CoV-2 infection
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
研究组 & 干预措施
[14C]RIST4721
[14C]RIST4721 oral solution
干预措施: [14C]RIST4271 (Drug)
结局指标
主要结局
Collection of plasma, urine and fecal samples for structural identification
时间窗: Day 1 to Day 17
Collection of plasma, urine and fecal samples for quantification analysis
时间窗: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Ae
时间窗: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by CumAe
时间窗: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval
时间窗: Day 1 to Day 17
Mass balance recovery of total radioactivity in all excreta: CumAe
时间窗: Day 1 to Day 17
Mass balance recovery of total radioactivity in all excreta: Cum%Ae
时间窗: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by %Ae
时间窗: Day 1 to Day 17
Collection of plasma, urine and fecal samples for metabolite profiling
时间窗: Day 1 to Day 17
次要结局
未报告次要终点