NCT03525405已完成1 期
A Phase I, Open Label, Single Dose Study to Evaluate the Mass Balance of 14C-Napabucasin 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
- 8
- 试验地点
- 1
- 主要终点
- Pharmacokinetics for napabucasin and metabolites by assessing fecal concentration
研究概览
简要总结
This is a Phase I, single-center, open-label, single-sequence, study evaluating the absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a mixture 14C-radiolabeled and unlabeled material.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Dose
Experimental
干预措施: napabucasin (Drug)
结局指标
主要结局
Pharmacokinetics for napabucasin and metabolites by assessing fecal concentration
时间窗: Up to 12 days
Pharmacokinetics for napabucasin and metabolites by assessing plasma concentration
时间窗: 1 week
Pharmacokinetics for napabucasin and metabolites by assessing urinary concentration
时间窗: Up to 12 days
次要结局
- Number of Patients with Adverse Events(4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
The Absorption, Metabolism and Excretion of [14C]CM082 in HumanAdvanced Solid TumorNCT04434326AnewPharma4
Unknown
1 期
The Absorption, Metabolism and Excretion of [14C]Ensartinib in HumanALK-POSITIVE NSCLCNCT03804541Betta Pharmaceuticals Co., Ltd.6
已完成
1 期
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male VolunteersHealthy Male VolunteersNCT04810533Nanjing Sanhome Pharmaceutical, Co., Ltd.6
Unknown
1 期
The Absorption, Metabolism and Excretion of [14C]D-0316 in HumanAdvanced or Metastatic Non-small Cell LungNCT04464551Betta Pharmaceuticals Co., Ltd.4
已完成
1 期
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.TuberculosisNCT03202693Global Alliance for TB Drug Development6