NCT02060266已完成1 期
A Single Centre, Open Label Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male 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
- Concentration of the major metabolites of [3H]-semaglutide in plasma, urine, and faeces
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion after a single subcutaneous dose of [3H]-semaglutide in healthy male subjects.
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
- 45 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, based on an assessment of medical history, physical examination, ECG (electrocardiogram) and vital signs, as determined by the investigator
- •Age between 45-64 years (both inclusive) at the time of signing inform consent
- •Body mass index (BMI) between 20 and 30 kg/m^2 (both inclusive)
排除标准
- •Donation of any blood or plasma in the past month or in excess of 100 mL within the 3 months preceding screening, or surgery or trauma with more than 100 mL blood loss within the 3 months preceding screening
- •Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to visit 2, Day 1
- •History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
- •History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
- •Smoking or use of any nicotine (including nicotine patches, gum, etc) in the last 3 months prior to screening or a positive nicotine test
研究组 & 干预措施
Semaglutide
Experimental
干预措施: semaglutide (Drug)
结局指标
主要结局
Concentration of the major metabolites of [3H]-semaglutide in plasma, urine, and faeces
时间窗: Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide
次要结局
- Total amount of [3H]-semaglutide related material excreted in urine (% of dose)(Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide)
- Total amount of [3H]-semaglutide related material excreted in faeces (% of dose)(Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide)
- Blood to plasma ratio of [3H]-semaglutide related material(Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide)
- Area under the semaglutide plasma concentration curve(From time 0 until infinity after a single dose)
- Maximum observed semaglutide plasma concentration(After a single dose)
研究者
研究点 (1)
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