NCT02877355已完成1 期
Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes
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
- 55
- 试验地点
- 1
- 主要终点
- Area under the semaglutide plasma concentration-time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is, to investigate the effect of upper gastrointestinal disease on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 18.5-39.9 kg/m^2 (both inclusive)
- •Subjects diagnosed clinically with type 2 diabetes mellitus for at least 180 days prior to the first screening visit
- •For subjects with upper gastrointestinal (GI) disease: Diagnosed with chronic gastritis and/or gastroesophageal reflux disease (GERD) at screening
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measures as required by local regulation or practice). (Highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner)
- •History of pancreatitis (acute or chronic)
- •History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- •Unable or unwilling to refrain from smoking during the in-patient periods
- •Any blood draw in excess of 50 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within 90 days of the first screening visit
研究组 & 干预措施
Semaglutide
Experimental
干预措施: semaglutide (Drug)
结局指标
主要结局
Area under the semaglutide plasma concentration-time curve
时间窗: From 0 to 24 hours after the 10th dosing
次要结局
- Maximum observed semaglutide plasma concentration(From 0 to 24 hours after the 10th dosing)
- Area under the SNAC plasma concentration-time curve(During a dosing interval (0 to 24 hours) at steady state)
- Maximum observed SNAC plasma concentration(During a dosing interval (0 to 24 hours) at steady state)
研究者
研究点 (1)
Loading locations...
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