NCT02231684已完成1 期
A Randomised, Single Centre, Two Period, Incomplete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide
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
- 42
- 主要终点
- Area under the semaglutide plasma concentration curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of three different strengths of semaglutide and the absolute bioavailability of semaglutide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy male or female subjects (based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the investigator)
- •Age between 18 and 55 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 20 and 30 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 not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control for the duration of the trial and for 5 weeks following the last dose of semaglutide. 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 (except routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
- •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 or use of any nicotine products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive nicotine test
研究组 & 干预措施
s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)
Experimental
干预措施: semaglutide (Drug)
s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
Experimental
干预措施: semaglutide (Drug)
s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)
Experimental
干预措施: semaglutide (Drug)
s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)
Experimental
干预措施: semaglutide (Drug)
s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)
Experimental
干预措施: semaglutide (Drug)
s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
Experimental
干预措施: semaglutide (Drug)
i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
Experimental
干预措施: semaglutide (Drug)
s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml)
Experimental
干预措施: semaglutide (Drug)
结局指标
主要结局
Area under the semaglutide plasma concentration curve
时间窗: From day 0-day 35/840 hours
次要结局
- Maximum observed semaglutide plasma concentration(From the concentration-time curves 0 - 840 hours following s.c. administration of a single dose 0.5 mg semaglutide at different strengths)
- Area under the semaglutide plasma concentration-time curve(From the concentration-time curves 0 - 840 hours following i.v. administration of a single dose 0.25 mg semaglutide (1 mg/mL))
- Number of treatment emergent adverse events (TEAEs)(From baseline (Visit 2, Day 1) to follow-up (12-14 weeks after Visit 2))
研究者
相似试验
已完成
2 期
Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01697618Novo Nordisk A/S13
已完成
1 期
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy VolunteersCongenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With InhibitorsHealthyNCT01563471Novo Nordisk A/S39
已完成
1 期
Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese SubjectsCongenital Bleeding DisorderHaemophilia AHaemophilia BHealthyNCT01555749Novo Nordisk A/S8
已完成
1 期
Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01524809Novo Nordisk A/S26
已完成
1 期
Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes MellitusDiabetesDiabetes Mellitus, Type 1NCT02536859Novo Nordisk A/S60