NCT04637139已完成1 期
An Open Label Phase 1 Study in Healthy Adult Male Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] Vebicorvir Following Single Oral Dose Administration
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: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C)
研究概览
简要总结
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History or presence of any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass)
- •Clinically significant abnormal medical history
- •History of cancer that has not been in full remission for >5 years
- •Acute illness within 14 days prior to study drug administration
研究组 & 干预措施
Group 1
Experimental
VBR 300 mg solution containing 2 µCi [14C]VBR
干预措施: Vebicorvir (VBR) (Drug)
结局指标
主要结局
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C)
时间窗: Before dosing and at prespecified time intervals up to 168 hours after dosing
Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Feces up to the Last Sampling Interval (Ae-feces, 14C)
时间窗: Before dosing and at prespecified time intervals up to 168 hours after dosing
次要结局
- Number of Participants Discontinued from the Study Due to an Adverse Event(Up to 168 hours)
- Number of Participants with One or More Adverse Events(Up to 168 hours)
研究者
研究点 (1)
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