A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects: A Randomised, Double-Blind,Placebo-Controlled, Three-Arm Parallel Trial With a Nested Cross-Over Design for Positive Control With Moxifloxacin Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- QTcI, (Individual heart rate corrected QT (Interval in the ECG: from the start of the QRS complex to the end) interval) based on ECG recordings obtained at 11 time points
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to evaluate the effect of semaglutide on cardiac repolarisation in healthy 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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI (Body Mass Index): 20-30 kg/m^2
- •Body weight: 60-110 kg
- •Normal ECG (electrocardiogram)
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 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 devices), or sexual abstinence or vasectomised partner
- •Any clinically significant disease history, in the opinion of the investigator, or systemic or organ
- •History of seizures, epilepsy, syncope, cardiac arrest, cardiac arrhythmia or Torsades de Pointes, A-V (Atrioventricular) block or structural heart disease
- •Family history of long QT (Interval in the ECG: from the start of the QRS complex to the end) syndrome (either objectively diagnosed or suggested by sudden death due to cardiac causes before the age of 50 of a 1st degree relative)
- •Family history of sudden cardiac death before the age of 50 of a 1st degree relative
- •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 halflives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
- •Smoking, drug or alcohol abuse
研究组 & 干预措施
Arm 1: semaglutide + moxifloxacin placebo
Subjects will receive a single dose of moxifloxacin placebo both before the start of semaglutide treatment and at the end of the semaglutide treatment.
干预措施: semaglutide (Drug)
Arm 1: semaglutide + moxifloxacin placebo
Subjects will receive a single dose of moxifloxacin placebo both before the start of semaglutide treatment and at the end of the semaglutide treatment.
干预措施: placebo (Drug)
Arm 2A:
Semaglutide placebo + moxifloxacin/moxifloxacin placebo:
Subjects will receive moxifloxacin before the start of semaglutide placebo treatment and moxifloxacin placebo at the end of the semaglutide placebo treatment.
干预措施: placebo (Drug)
Arm 2A:
Semaglutide placebo + moxifloxacin/moxifloxacin placebo:
Subjects will receive moxifloxacin before the start of semaglutide placebo treatment and moxifloxacin placebo at the end of the semaglutide placebo treatment.
干预措施: moxifloxacin (Drug)
Arm 2B:
Semaglutide placebo + moxifloxacin placebo/moxifloxacin:
Subjects will receive moxifloxacin placebo before the start of semaglutide placebo treatment and moxifloxacin at the end of the semaglutide placebo treatment.
干预措施: placebo (Drug)
Arm 2B:
Semaglutide placebo + moxifloxacin placebo/moxifloxacin:
Subjects will receive moxifloxacin placebo before the start of semaglutide placebo treatment and moxifloxacin at the end of the semaglutide placebo treatment.
干预措施: moxifloxacin (Drug)
结局指标
主要结局
QTcI, (Individual heart rate corrected QT (Interval in the ECG: from the start of the QRS complex to the end) interval) based on ECG recordings obtained at 11 time points
时间窗: 0-48 hours after the fourth dose of semaglutide/semaglutide placebo at the 1.5 mg dose level
次要结局
- QTcI, based on ECG (electrocardiogram) recordings obtained at 2 out of 8 time points(0-24 hours after a single dose of moxifloxacin/moxifloxacin placebo)