NCT02023606已完成1 期
An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion (AME) of [14C] Labeled SPN-810M in 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
- 7
- 试验地点
- 1
- 主要终点
- Urinary and fecal recoveries (mass balance) of total radioactivity.
研究概览
简要总结
An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion of Radio Labeled SPN-810M in Healthy Adult 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
- 30 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SPN-810M
Experimental
Single dose of 20 mL solution containing 50 mg of SPN-810M and no less than 8.5 MBq (225 µCi) carbon-14 (14C)-SPN-810M, and no more than 11.3 MBq (305 µCi) [14C] SPN-810M.
干预措施: SPN-810M (Drug)
结局指标
主要结局
Urinary and fecal recoveries (mass balance) of total radioactivity.
时间窗: 10 days post dose.
C(urine and feces), Ae(urine and feces), CumAe(urine and feces), % Dose(urine and feces), CUM% Dose(urine and feces).
次要结局
- Whole blood and plasma partitioning of total radioactivity.(10 days post dose.)
- Pharmacokinetics (PK) of total radioactivity in plasma.(10 days post dose.)
- PK of SPN-810 in plasma.(10 days post dose.)
- PK of the major metabolites of SPN-810 in plasma.(10 days post dose.)
- Metabolites of SPN-810 in plasma, urine and feces(10 days post dose.)
- Safety and tolerability of SPN-810.(10 days post dose.)
研究者
研究点 (1)
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