NCT00976326已完成1 期
A Trial Investigating the Pharmacokinetic and Safety Profiles of NN1250 in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment and in Subjects With Normal 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
- 12
- 试验地点
- 1
- 主要终点
- Area under the NN1250 concentration-time curve after single-dose
研究概览
简要总结
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Subject with normal hepatic function, liver parameters within normal range. Not assessed with the Child-Pugh criteria. Or: Subject with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by Investigator
- •Body mass index maximum 40.0 kg/m^2
排除标准
- •Subject with any disease or condition which the Investigator feels would interfere with the trial outcome or execution except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Not able or willing to refrain from smoking during the inpatient period
研究组 & 干预措施
A: Healthy volunteers
Experimental
干预措施: insulin degludec (Drug)
B: Subjects with mild liver impairment
Experimental
干预措施: insulin degludec (Drug)
C: Subjects with moderate liver impairment
Experimental
干预措施: insulin degludec (Drug)
D: Subjects with severe liver impairment
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Area under the NN1250 concentration-time curve after single-dose
时间窗: from 0 to 120 hours
次要结局
- Maximum observed NN1250 concentration after single-dose(from 0 to 120 hours)
- Number of adverse events(from Visit 2, Day -1 until Follow-up Visit)
- Renal clearance of NN1250(from 0 to 24 hours)
研究者
研究点 (1)
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