A Double-blind, Randomized, Four-period Crossover Study to Assess the Effects of Single Oral Dose Dapagliflozin Administration on QTc Interval Compared to Placebo, Using AVELOX™ (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Age 18 to 45 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Electronic measures of heart beats
研究概览
简要总结
The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males age 18 to 45 years of age, who are not currently taking any medications
- •Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)
排除标准
- •No personal or family history of significant heart problems
- •No use of over the counter medications within 7 days of the study
- •No use of prescription medicaiton within 1 month of the study
研究组 & 干预措施
20 mg single dose of dapagliflozin
20 mg dapagliflozin
干预措施: Dapagliflozin (Drug)
20 mg single dose of dapagliflozin
20 mg dapagliflozin
干预措施: Moxifloxacin (Drug)
20 mg single dose of dapagliflozin
20 mg dapagliflozin
干预措施: Placebo to match moxifloxacin and dapagliflozin (Drug)
150 mg single dose of dapagliflozin2
150 mg dapagliflozin
干预措施: Dapagliflozin (Drug)
150 mg single dose of dapagliflozin2
150 mg dapagliflozin
干预措施: Moxifloxacin (Drug)
150 mg single dose of dapagliflozin2
150 mg dapagliflozin
干预措施: Placebo to match moxifloxacin and dapagliflozin (Drug)
400 mg single dose of moxifloxacin
Moxifloxacin
干预措施: Dapagliflozin (Drug)
400 mg single dose of moxifloxacin
Moxifloxacin
干预措施: Moxifloxacin (Drug)
400 mg single dose of moxifloxacin
Moxifloxacin
干预措施: Placebo to match moxifloxacin and dapagliflozin (Drug)
Placebo
Placebo
干预措施: Dapagliflozin (Drug)
Placebo
Placebo
干预措施: Moxifloxacin (Drug)
Placebo
Placebo
干预措施: Placebo to match moxifloxacin and dapagliflozin (Drug)
结局指标
主要结局
Electronic measures of heart beats
时间窗: ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication
次要结局
- Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers(At scheduled times during the 3 day periods following dosing during each of the 4 study periods)
- Safety and tolerability of dapagliflozin(Screening through completion of the study)