NCT01028768已完成1 期
Open Label Pharmacokinetic (PK) Study, Conducted at One Investigational Site in Germany, to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Teduglutide Following Subcutaneous Administration of 10 mg Teduglutide and to Evaluate Safety and Tolerability of 10 mg Teduglutide
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of teduglutide
研究概览
简要总结
To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide.
Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A further objective is the description of the PK of teduglutide following SC administration of 10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy subjects.
详细描述
Pharmacokinetic study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subjects with moderate, severe and end stage renal failure and matched healthy controls.
排除标准
- 未提供
研究组 & 干预措施
Teduglutide
Experimental
干预措施: Teduglutide (Drug)
结局指标
主要结局
Pharmacokinetics of teduglutide
时间窗: 24 hrs
次要结局
- Safety and tolerability of 10 mg teduglutide (assessed by physical examination, vital signs, clinical laboratory, electrocardiogram [ECG] and adverse events [AE])(7 days)
研究者
研究点 (1)
Loading locations...
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