NCT04415645已完成1 期
Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of [14C]-VVZ-149 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
- Total radioactivity (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 IV infusion of [14C]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion 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
- Other
- 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
- •Healthy, adult, male, 19-55 years of age, inclusive
- •Continuous non-smoker
- •BMI ≥ 18.0 and ≤ 32.0 kg/m2
- •Medically healthy with no clinically significant medical history or findings
- •Must agree to adhere to the contraception requirements
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease
- •History or presence of alcohol or drug abuse within the past 2 years
- •History, presence or evidence of cardiovascular, renal or hepatic impairment
- •Less or abnormal bowel movements
- •Unable to refrain from or anticipates the use of any prohibited drugs
- •Recent donation of blood/plasma or significant blood loss
- •Radiation exposure within 12 months
- •Participation in another clinical study within 30 days
研究组 & 干预措施
VVZ-149 Injections
Experimental
干预措施: [14C]-VVZ-149 (Drug)
结局指标
主要结局
Total radioactivity (TRA) concentration equivalents in plasma
时间窗: Day 15
TRA concentration equivalents in urine
时间窗: Day 15
TRA concentration equivalents in feces
时间窗: Day 15
Drug concentrations in plasma
时间窗: Hour 48
Mass balance
时间窗: Day 15
Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose
次要结局
- Treatment-emergent adverse events(Day 15)
研究者
研究点 (1)
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