NCT01507389已完成1 期
A Single-centre, Open-label Trial Investigating the Pharmacokinetics and the Safety Profile After a Single Dose of Liraglutide in Subjects With 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
- 24
- 主要终点
- Area under the Curve (0-infinity)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects with normal hepatic 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
- •Subjects with normal hepatic function and liver parameters within normal range
- •Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C
- •Body Mass Index between 18.5-40.0 kg/m^2 (both inclusive)
排除标准
- •Known or suspected allergy to trial product or related products
- •Liver transplanted subjects
- •Cardiac problems
- •Uncontrolled treated/untreated hypertension
- •Signs of acute liver insufficiency
- •Positive HIV (human immunodeficiency virus) 1+2 antibodies
- •Cancer or any clinically significant disease or disorder except for conditions associated with the hepatic impairment
- •Impaired renal function
- •Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
- •Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
研究组 & 干预措施
Mild
Experimental
干预措施: liraglutide (Drug)
Moderate
Experimental
干预措施: liraglutide (Drug)
Severe
Experimental
干预措施: liraglutide (Drug)
Normal
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Area under the Curve (0-infinity)
次要结局
- Area under the Curve (0-t)
- Cmax, maximum concentration
- tmax, time to maximum concentration
- t½, terminal half-life
- Adverse events
研究者
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