NCT02243098已完成1 期
An Open-label, One-sequence Cross Over, Single Centre Trial, Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy 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
- 31
- 试验地点
- 1
- 主要终点
- Area under the atorvastatin plasma concentration-time curve
研究概览
简要总结
The trial is conducted in Europe. The aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
- •Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive)
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control throughout the trial including the 5 weeks follow-up period. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner
- •Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- •Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal supplements, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (first dose administration)
- •History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
- •History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
- •Smoking in the last 3 months prior to screening or a positive nicotine test
研究组 & 干预措施
Semaglutide
Experimental
干预措施: semaglutide (Drug)
Semaglutide
Experimental
干预措施: digoxin (Drug)
Semaglutide
Experimental
干预措施: atorvastatin (Drug)
结局指标
主要结局
Area under the atorvastatin plasma concentration-time curve
时间窗: From time 0 to 72 hours after a single dose
Area under the digoxin plasma concentration-time curve
时间窗: From time 0 to 120 hours after a single dose
次要结局
- Maximum observed atorvastatin plasma concentration(From time 0 to 72 hours after a single dose)
- Maximum observed digoxin plasma concentration(From time 0 to 120 hours after a single dose)
- Number of treatment emergent AEs (TEAEs)(From baseline (Visit 2, Day 1) to follow-up (Visit 12, 20 weeks after baseline))
研究者
研究点 (1)
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