A Placebo- and Positive-Controlled Study of the Effect of LY2484595 on QT Interval in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo
研究概览
简要总结
The purpose of this study is to evaluate the effect on the electrical activity of the heart as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to 10 days of placebo in relation to a single dose of moxifloxacin. Information about any side effects that occur will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females
- •Body mass index (BMI) of 18.5 to 29 kilograms per square meter (kg/m²)
- •Reliable and willing to be available for the duration of the study and are willing to follow study procedures
- •Provided written informed consent
排除标准
- •Known allergies to LY2484595 or moxifloxacin
- •Personal or family history of long QT syndrome, heart failure, or low blood potassium (hypokalemia) a family history of sudden death, or unexplained syncope within the last year
- •Positive findings on urinary drug screening
- •Cigarette smokers
研究组 & 干预措施
Placebo
Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period.
干预措施: Placebo (Drug)
1200 milligrams (mg) LY2484595
Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period.
干预措施: LY2484595 (Drug)
400 mg Moxifloxacin
Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods, separated by at least a 14-day washout period.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo
时间窗: Predose of Day 1, Day 10
Data were collected using a 12-lead electrocardiogram (ECG). The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle and corrected for heart rate. Population-corrected QT interval (QTcP) formula: QTcP = QT / RR\^ß, where ß is the population correction factor.
次要结局
- Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2484595 During One Dosing Interval at Steady State(Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose)
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2484595 During One Dosing Interval at Steady State(Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose)
- Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins(Baseline, Day 11)