A Randomised, 4-period, Placebo and Active-controlled, Single-dose, Change-over Trial to Evaluate the Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).
研究概览
简要总结
The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration), pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a screening and a treatment phase of four treatment periods. There is a washout period of at least 7 days and 4 weeks at maximum between administrations. The expected total trial duration for the individual subject will be about 7 weeks (maximum 17) weeks.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or female volunteers
- •Normal body weight (body mass index within ≥18 and 29 kg/m2 (inclusive) and a body weight >50 kg (females) and >60 kg (males).
排除标准
- 未提供
研究组 & 干预措施
Teduglutide 5 mg
Treatment A, subcutaneous injection
干预措施: Teduglutide (Drug)
Teduglutide 20 mg
Treatment B, subcutaneous injection
干预措施: Teduglutide (Drug)
Placebo
subcutaneous injection
干预措施: Teduglutide (Drug)
Moxifloxacin
400 mg, oral
干预措施: Teduglutide (Drug)
结局指标
主要结局
ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).
时间窗: until 24 h post dose
次要结局
- ECG measurement/assessment to determine the effect of a single dose of a positive control, moxifloxacin, on cardiac repolarisation, heart rate, and conduction(until 24 h post dose)
- ECG measurement/assessment to determine the effect of a single dose of teduglutide on heart rate and cardiac conduction (RR and PR intervals, QRS duration)(until 24 h post dose)
- PK blood samples to investigate pharmacokinetics of teduglutide in plasma(until 24 h post dose)
- PK blood samples to explore the concentration effect relationship on QT/QTc intervals(until 24 h post dose)
- ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide(within 14 days after trial medication administration)