An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-SAR442168 (Not More Than 3.7 MBq) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percentage of radioactive dose excreted in urine and feces
研究概览
简要总结
Primary Objective:
To determine the excretion balance and systemic exposure of radioactivity after oral administration of [14C]-SAR442168.
To determine the pharmacokinetics of SAR442168 and its contribution to the overall exposure of radioactivity.
To collect samples in order to determine the metabolic pathways of SAR442168 and identify the chemical structures and main excretion route of the main metabolites (samples will be analyzed according to metabolic analysis plan and results will be documented in a separate report).
Secondary Objective:
To assess the clinical and biological tolerability of an oral solution of SAR442168.
详细描述
Total study duration is 3 to 10 weeks, including a screening period of 27 days, treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR442168
Single oral dose of SAR442168 (as a nonsalified compound) containing (NMT) 3.7 MBq of [14C]-SAR442168
干预措施: SAR442168 (Drug)
结局指标
主要结局
Percentage of radioactive dose excreted in urine and feces
时间窗: Day 1 to Day 43
Fractional and cumulative percentage of radioactive dose excreted in urine and feces of \[14C\]-SAR442168
次要结局
- Number of subjects with Adverse events(From Day -1 to 43)
- Blood/plasma radioactivity ratio(Day 1 up to Day 43)
- Plasma SAR442168 /radioactivity ratio(Day 1 up to Day 43)