NCT01866748已完成1 期
Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation 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
- 170
- 主要终点
- Part A: Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator
- •Body Mass Index (BMI) between 20 and 30 kg/m^2
- •Glycosylated haemoglobin (HbA1c) below 6.0% (only in Part B)
排除标准
- •History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- •Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted
研究组 & 干预措施
Part A (single dose)
Experimental
干预措施: semaglutide (Drug)
Part A (single dose)
Experimental
干预措施: placebo (Drug)
Part B (multiple dose)
Experimental
干预措施: semaglutide (Drug)
Part B (multiple dose)
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Part A: Number of treatment emergent adverse events (TEAEs)
时间窗: Day -1 to Day 24
Part B: Number of treatment emergent adverse events (TEAEs)
时间窗: Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104)
次要结局
- Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve(Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69))
- Part B: Change in fasting plasma glucose (FPG) from baseline(Day 0 (pre-dose), day 70)
- Part B: Change in body weight from baseline(Day -1, day 70)
- Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve(From time 0 to 24 hours after a single dose (Day 0))
研究者
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