A Trial Comparing Exposure of Semaglutide When Dosing New Formulations of Oral Semaglutide to Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing
研究概览
简要总结
This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.
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 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive). - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening. - Use of tobacco and nicotine products, defined as any of the below: a) Smoking more than 5 cigarettes or the equivalent per day. b) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s). - History* of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. - Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma*. - History* or presence of pancreatitis (acute or chronic). *As declared by subject.
研究组 & 干预措施
Oral semaglutide (reference)
Participants will receive oral semaglutide (reference) for 10 days.
干预措施: Semaglutide 3 mg (Drug)
Oral semaglutide (reference)
Participants will receive oral semaglutide (reference) for 10 days.
干预措施: Semaglutide 7 mg (Drug)
Oral semaglutide formulation B
Participants will receive oral semaglutide formulation B for 10 days.
干预措施: Semaglutide B 3 mg (Drug)
Oral semaglutide formulation B
Participants will receive oral semaglutide formulation B for 10 days.
干预措施: Semaglutide B 7 mg (Drug)
Oral semaglutide formulation C
Participants will receive oral semaglutide formulation C for 10 days.
干预措施: Semaglutide C 3 mg (Drug)
Oral semaglutide formulation C
Participants will receive oral semaglutide formulation C for 10 days.
干预措施: Semaglutide C 7 mg (Drug)
Oral semaglutide formulation D
Participants will receive oral semaglutide formulation D for 10 days.
干预措施: Semaglutide D 3 mg (Drug)
Oral semaglutide formulation D
Participants will receive oral semaglutide formulation D for 10 days.
干预措施: Semaglutide D 7 mg (Drug)
结局指标
主要结局
AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing
时间窗: 0 to 24 hours on day 10
Calculated based on semaglutide measured in blood.
次要结局
- Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing(0 to 24 hours on day 10)
- tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing(0 to 24 hours on day 10)
- t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing(Days 10-45)
- AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing(0 to 30 minutes on day 10)
- Number of treatment emergent adverse events(Days 1-47)