A Phase I Mass Balance and Metabolism Study of 14C-Z-215 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- Mass balance recovery of total radioactivity concentration in plasma, red blood cells and whole blood
研究概览
简要总结
The aim of this Phase I study is to determine the absorption, metabolism, and excretion of 14C-Z-215 in healthy male subjects following a single oral administration at a therapeutically relevant dose level (20 mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Any race/ethnic origin
- •Subjects will have a body mass index (BMI) between 18.5 and 30.0 kg/m2
- •Subjects will have a body weight between 50 and 110 kg
- •Subjects will have given their written informed consent to participate in the study, and to abide by the study restrictions.
排除标准
- •Subjects who have a significant history of drug allergy, as determined by the Investigator.
- •Subjects who have serum hepatitis or are carriers of the hepatitis B surface antigen (HBsAg) or the hepatitis C antibody.
- •Subjects who have a positive result for the test for human immunodeficiency virus (HIV) antibodies.
- •Subjects who are exposed to radiation as a result of their occupation.
- •Subjects who, in the opinion of the Investigator, should not participate in this study.
研究组 & 干预措施
14C-Z-215
干预措施: 14C-Z-215 (Drug)
结局指标
主要结局
Mass balance recovery of total radioactivity concentration in plasma, red blood cells and whole blood
时间窗: Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours postdose
Concentration of Z-215 in plasma
时间窗: Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours postdose
Mass balance recovery of total radioactivity in urine
时间窗: Predose, 0 to 6, 6 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240 hours postdose, Day 15 (336 hours postdose), Day 19 (432 hours postdose), Day 23 (528 hours postdose)
Mass balance recovery of total radioactivity in faecal
时间窗: Predose, 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240 hours postdose, Day 15 (336 hours postdose), Day 19 (432 hours postdose), Day 23 (528 hours postdose)
次要结局
未报告次要终点