NCT01572753已完成1 期
A Single Centre, Multiple Dose, Open Label Randomised Trial to Evaluate the Effect of Post Dose Meal Timings and the Effect of Volume of Water With Dosing on the Pharmacokinetic Properties of Oral 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
- 161
- 试验地点
- 1
- 主要终点
- AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ECG), vital signs and clinical laboratory
- •Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)
排除标准
- •Males who are sexually active and not surgically sterilised, who or whose partner(s): a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a Pearl Index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. In addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication or c. sterilization of either partner
- •Suffer from a life threatening disease or has a history of any clinically significant disease or disorder
- •History of acute idiopathic or chronic pancreatitis
- •Calcitonin value equal to or above 50 ng/L
- •Any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the investigator and any of the following laboratory safety results (based on screening results): Amylase, lipase and creatinine, above upper normal range. Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyl-transpeptidase (gamma-GT) above 1.5 times upper normal range (UNR). Thrombocytes below 0.75 times lower normal range (LNR) or above 1.25 times UNR. Leucocytes outside 3.0 to 11.0x10^9/L (normal range is 3.91 to 8.77x10^9/L. Sodium outside the range 130.0 to 150.0 mmol/L (normal range is 136-145 mmol/L). Potassium outside the range 3.0 to 5.5 mmol/L (normal range is 3.5 to 5.1 mmol/L)
- •Any clinically significant abnormal ECG, as judged by the investigator
- •Subjects who are smokers
研究组 & 干预措施
Post-dose fasting 120 mins/50 ml water
Experimental
干预措施: semaglutide (Drug)
Post-dose fasting 60 mins/50 ml water
Experimental
干预措施: semaglutide (Drug)
Post-dose fasting 30 mins/50 ml water
Experimental
干预措施: semaglutide (Drug)
Post-dose fasting 15 mins/50 ml water
Experimental
干预措施: semaglutide (Drug)
Post-dose fasting 120 mins/120 ml water
Experimental
干预措施: semaglutide (Drug)
Post-dose fasting 60 mins/120 ml water
Experimental
干预措施: semaglutide (Drug)
Post-dose fasting 30 mins/120 ml water
Experimental
干预措施: semaglutide (Drug)
Post-dose fasting 15 mins/120 ml water
Experimental
干预措施: semaglutide (Drug)
结局指标
主要结局
AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing
时间窗: 0-24hrs after the 10th dosing
次要结局
- t1/2; the terminal half-life of semaglutide(Post-dose at day 10)
- Cmax; The maximum plasma semaglutide concentration(Post-dose at day 10)
- tmax; Time to maximum plasma semaglutide concentration(Post-dose at day 10)
研究者
研究点 (1)
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