NCT01517568已完成1 期
A Single-Centre, Open Label Trial Investigating the Metabolites in Plasma, Urine and Faeces After a Single Subcutaneous Dose of [3H]-Liraglutide to Healthy Subjects
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
- 7
- 试验地点
- 1
- 主要终点
- Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is characterise the metabolic profile of liraglutide in plasma, urine, and faeces after a single injection of [3H]-liraglutide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Good general health as judged by the Investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments
- •BMI (Boday Mass Index) of 20.0-27.0 kg/m^2, both inclusive
排除标准
- •History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
- •Impaired renal function
- •Active hepatitis B or active hepatitis C
- •Positive human immunodeficiency virus (HIV) antibodies
- •Any clinically significant abnormal ECG, as judged by the Investigator
- •Any clinically significant abnormal laboratory test results, as judged by the Investigator
- •Acute infection or inflammation or other illness that may influence the metabolism and excretion pattern of the trial product, as judged by the Investigator
- •Known or suspected allergy to trial product(s) or related products
- •History of alcoholism or drug abuse or positive results in alcohol and drug screens
- •Smoking of more than 5 cigarettes per day
- •Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
- •Excessive consumption of a diet deviating from a normal diet, as judged by the Investigator
研究组 & 干预措施
Liraglutide
Experimental
干预措施: liraglutide [3H] (Drug)
结局指标
主要结局
Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces
Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces
次要结局
- tmax, time to reach Cmax
- Adverse events
- Area under the curve
- t½, terminal half-life
- The distribution of [3H]-liraglutide in whole blood versus plasma
- Cmax, maximum concentration
研究者
研究点 (1)
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