NCT06974292已完成1 期
The Mass Balance and Biotransformation Study of [14C]VC005 in Chinese Healthy Adult Male Volunteers
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
- Cumulative excretion rate of radioactivity in urine
研究概览
简要总结
This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]VC005 orally in Chinese healthy male volunteers.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy male adult.
- •Age is between 18 and 45, inclusive.
- •Weight ≥ 50 kg and Body mass index is between 19 and 26, inclusive.
- •Voluntarily to provide informed consent form.
- •Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.
排除标准
- •Any abnormal and clinical significant findings to physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine+occult blood, thyroid function), 12 lead electrocardiogram, chest X-ray (upright position), abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), anal directorial rectum examination, and so on.
- •Tested positive for any one of the following: HBsAg/HBeAg, Anti-HCV IgG, HIV-Ag/Ab or treponema pallidum antibody (Syphilis) .
- •Volunteers who have to work in radioactive conditions in long time, participated in radio-labeled drug clinical trial or had significant radioactive exposure within one year before the trial, more than 2 times of chest/abdominal CT, or more than 3 times of different types of X-ray exam.
- •Volunteers are not suitable for this clinical trial, in the opinions of investigators.
研究组 & 干预措施
[14C]VC005
Experimental
干预措施: [14C]VC005 (Drug)
结局指标
主要结局
Cumulative excretion rate of radioactivity in urine
时间窗: from 0 hour to 216 hours after administration
Cumulative excretion rate of radioactivity in feces
时间窗: from 0 hour to 216 hours after administration
Total radioactivity
时间窗: from 0 hour to 216 hours after administration
次要结局
- Adverse events(From signing the ICF until 10 days after the dosing)
研究者
研究点 (1)
Loading locations...
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