A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- QTc interval
研究概览
简要总结
This study is designed to investigate the effect of treatment with albiglutide on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.
详细描述
This is a Phase I, randomized, double-blind study designed to investigate the effect of treatment with albiglutide given weekly over 6 weeks on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Healthy male or nonpregnant, nonlactating female
- •Subject considered to be in good health as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values
- •BMI is ≥18 kg/m2 and ≤30 kg/m2
- •Nonsmoker
排除标准
- •Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
- •History of arrythmia or use of antiarrhythmic agents
- •History of any anaphylactic reaction to any drug
- •History of significant cardiovascular or pulmonary dysfunction
- •Current or chronic history of liver disease , renal disease, CNS disorders, thyroid dysfunction, rheumatoid arthritis
- •History of alcohol or substance abuse
- •History of GI surgery that could influence gastric emptying
- •Female and using oral contraception (combined or progestogen only), implants or levonorgestrel, or injectable progesterone, or hormone replacement therapy
- •History of pancreatitis
研究组 & 干预措施
Albiglutide + moxifloxacin placebo
Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40
干预措施: Albiglutide (Biological)
Albiglutide matching placebo + moxifloxacin
Once weekly subcutaneous injection of albiglutide matching placebo for 6 weeks, given with oral 400mg moxifloxacin tablet on Day -1 and moxifloxacin matching placebo on Day 40, or weekly albiglutide matching placebo for 6 weeks plus oral moxifloxacin matching placebo on Day -1 then oral 400mg moxifloxacin on Day 40
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
QTc interval
时间窗: 6 weeks
Measurement of cardiac repolarization after albiglutide dosing
次要结局
- Number of participants with adverse events(6 weeks)
- QTc interval(Day 4)
- QT interval(Day -1 and Day 40)