NCT05004415已完成1 期
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-AT-527 in Healthy Adult 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
Mass balance study of AT-527 in Healthy Male Subjects.
详细描述
This is an open-label, single-dose study assessing the absorption, metabolism, excretion, and mass balance of [14C]-AT-527 in healthy adult 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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
- •No clinically significant diseases captured in the medical history or clinically significant findings at screening physical examination.
- •A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to dosing. A male who has been vasectomized less than 4 months prior to dosing must follow the same restrictions as a non-vasectomized male).
- •Willing to comply with the study requirements and to provide written informed consent
排除标准
- •Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
- •Abuse of alcohol or drugs
- •Use of other investigational drugs within 28 days of dosing
- •Other clinically significant medical conditions or laboratory abnormalities
研究组 & 干预措施
AT-527 550 mg (R07496998)
Experimental
干预措施: AT-527 (R07496998) (Drug)
结局指标
主要结局
Mass Balance
时间窗: Day 1 to Day 15
Percent of radioactive dose excreted in urine and feces
次要结局
未报告次要终点
研究者
研究点 (1)
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