NCT02161588已完成1 期
A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian 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
- 48
- 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 Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), safety and tolerability of oral semaglutide in healthy male Japanese and Caucasian 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
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male Japanese and Caucasian subjects
- •Age between 20 and 55 years (both inclusive) at time of signing informed consent
- •Body weight of above or equal to 54.0 kg
- •Body mass index (BMI) between 20.0 and 25.0 kg/m^2 (both inclusive)
- •Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%
排除标准
- •Presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, GI (gastrointestinal), endocrine, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, as judged by the investigator. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Smoking of more than 5 cigarettes (including nicotine substitute products), or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
- •Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (Day 1), non-prescription drugs within 1 week prior to Visit 2 (Day 1). The use of vitamins and minerals, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
- •Any blood drawn in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
- •Previous GI surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder (e.g., cholecystectomy), pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic and gastric endoscopy
研究组 & 干预措施
Semaglutide
Experimental
干预措施: semaglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Area under the semaglutide plasma concentration-time curve
时间窗: During a dosing interval (0-24 hours) at steady state
次要结局
- Number of treatment emergent adverse events (TEAEs) recorded(From the time of first dosing (Day 1) until completion of the follow-up visit (Days 119-126))
- Maximum observed semaglutide plasma concentration(During a dosing interval (0-24 hours) at steady state)
研究者
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