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临床试验/NCT01028768
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

Nycomed1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2009年10月最近更新:
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

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

发起方
Nycomed
申办方类型
Industry

研究点 (1)

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