A randomized, single-dose, single blind, placebo controlled, cross over, validation study of moxifloxacin induced QT/QTc changes in healthy subjects of Indian origin (Indian subcontinent)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- QT changes as asseseed by ECG reading at
研究概览
简要总结
This is a randomized, single-dose, single blind, placebo controlled, cross over study in healthy subjects. All eligible subjects will participate in a screening period (up to 21 days), two baseline visit, two ECG baseline visits (Day -1) and two single dose treatment periods with a wash out period of 7 days between dosing. An end-of-study evaluation will be conducted 5-7 days after the last dose. The central reader of ECGs will be blinded with regard to time, subject, treatment and period identification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and/or female subjects, from 18-55 years of age and in good health.
- •Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.5 to 32 kg/m2
- •Female subjects must be: Surgically sterilized at least 6 months prior to study participation or Post-menopausal or must be using two acceptable barrier methods of contraception.
排除标准
- •Use of any prescription drug
- •Participation in any clinical investigation
- •QTcF at screening prolonged and past medical history of clinically significant ECG abnormalities
- •Donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing
- •Significant illness within the 2 weeks prior to initial dosing
- •History of or presence of risk factors for Torsade de pointes (TdP), including a family history of arrhythmia or sudden death, hypokalemia, hypomagnesia, family history of long QT syndrome
- •History of diabetes mellitus
- •History of hyperthyroidismOther exclusion critirea from protocol is applicable.
结局指标
主要结局
QT changes as asseseed by ECG reading at
时间窗: Screening*, baseline* (Day -2), ECG baseline (Day -1): equivalent pre-dose (8-10am) and 1, 1.5, 2, 3, 4, 6, and 12 hours post-dose; Day 1: pre-dose (24 hour post dose for Day -1)and the post-dose time points of: 1, 1.5, 2, 3, 4, 6,12 and 24 hours and end of study*.
次要结局
- To investigate the change from baseline in the ECG morphology(Mean difference in QTcB and other QTc parameters)