NCT00698464已完成1 期
A Phase I, Open-label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
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
- 34
- 试验地点
- 4
- 主要终点
- Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection.
研究概览
简要总结
The purpose of this study is to evaluate the effect of varying degrees of hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in subjects.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pasireotide
Experimental
干预措施: Pasireotide (Drug)
结局指标
主要结局
Determination of the pharmacokinetic profile of single dose of pasireotide s.c. injection.
时间窗: 5 days
次要结局
- Determination of the safety after a single dose of pasireotide s.c. injection(5 days)
研究者
研究点 (4)
Loading locations...
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