A Phase I, Randomized, Gender Stratified, Double-Blind, Placebo- and Positive-Controlled, Three Period Crossover Trial to Assess the Effect of Guanfacine Hydrochloride on QT/QTc Interval in Healthy Men and Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1
研究概览
简要总结
To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Normal Subjects
排除标准
- 未提供
研究组 & 干预措施
Immediate-release Guanfacine HCl
干预措施: immediate release guanfacine hydrochloride (Drug)
Moxifloxacin HCl
干预措施: moxifloxacin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1
时间窗: Baseline and Tmax (time of subject-specific maximum plasma concentration)
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).
Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1
时间窗: Baseline, Tmax (time of subject-specific maximum plasma concentration)
QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6
时间窗: Baseline and Tmax (time of subject-specific maximum plasma concentration)
QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1
时间窗: Baseline and Tmax (time of subject-specific maximum plasma concentration)
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6
时间窗: Baseline and Tmax (time of subject-specific maximum plasma concentration)
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Change From Baseline in Heart Rate (HR) at Tmax on Day 1
时间窗: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Heart Rate (HR) at Tmax on Day 6
时间窗: Baseline and Tmax (time of subject-specific maximum plasma concentration)
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6
时间窗: Baseline and Tmax (time of subject-specific maximum plasma concentration)
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).
次要结局
- Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1(pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose)
- Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6(pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose)
- Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1(pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose)
- Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6(pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose)
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1(pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose)
- Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6(pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose)