NCT01002469已完成不适用
Pilot Feasibility Study in Healthy Subjects and Healthy Asymptomatic Subjects Genetically Disposed to Urea Cycle Disorders to Evaluate the Use of 13 C Isotope Ratio Measurement
Cytonet GmbH & Co. KG2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline
研究概览
简要总结
In this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for patients with urea cycle disorders and to monitor the severity of the disease, a reliable and safe quantitative method for the measurement of the urea cycle flux is required.
Urea synthesis will be evaluated by administering sodium [1-13C]-acetate and measuring subsequent incorporation of [13C] label from Na-acetate into urea in healthy volunteers and asymptomatic subjects genetically disposed to urea cycle disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1 + 2: Healthy subjects
- •Group 3: Healthy asymptomatic subjects genetically disposed to urea cycle disorders
- •All: age 18 to 50 years (adult)
- •Written informed consent
排除标准
- •Presence of acute infection
- •Participation in other clinical trials within 30 days prior to inclusion
- •Severe coagulopathy
- •Severe systemic or chronic disease
- •Pregnancy or lactation
结局指标
主要结局
Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline
次要结局
- Cmax of absolute [13C]urea in plasma
研究者
研究点 (2)
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