A Phase 1, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- TRA concentration equivalents in plasma
研究概览
简要总结
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of [14C]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and plasma drug concentrations.
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
- •Body weight no less than 50 kg and body mass index (BMI) within the range of ≥ 18 and ≤ 33 kg/m2
- •Must have a minimum of 1 bowel movement every 2 days
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
排除标准
- •Inadequate venous access or unsuitable veins for repeated venipuncture
- •Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies, and/or Hepatitis B
研究组 & 干预措施
Mass Balance
干预措施: [14C]AR882 (Drug)
结局指标
主要结局
TRA concentration equivalents in plasma
时间窗: Days 1-14
Total radioactivity (TRA) in urine
时间窗: Days 1-14
TRA in feces
时间窗: Days 1-14
TRA concentration equivalents in whole blood
时间窗: Days 1-14
Area under the curve (AUC) for plasma [14C]-AR882
时间窗: 7 Days
Profile from plasma in terms of AUC following a single dose of \[14C\]-AR882
Time to maximum plasma concentration (Tmax) for [14C]-AR882
时间窗: 7 Days
Profile from plasma in terms of Tmax following a single dose of \[14C\]-AR882
Maximum plasma concentration (Cmax) for [14C]-AR882
时间窗: 7 Days
Profile from plasma in terms of Cmax following a single dose of \[14C\]-AR882
Apparent terminal half-life (t1/2) for [14C]-AR882
时间窗: 7 Days
Profile from plasma in terms of t1/2 following a single dose of \[14C\]-AR882
次要结局
- Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882(Days 1-14)