NCT02924337已完成1 期
A Randomised, Double-blind, Placebo and Active Controlled Crossover Study to Assess the Effect of Single Dose Administration of 2 Doses of Imeglimin on QT/QTc Intervals in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Poxel SA
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change from baseline in QTcF (deltaQTcF)
研究概览
简要总结
The purpose of this study is to assess the effect of a single therapeutic dose and a single supra-therapeutic dose of imeglimin on the QT/QTc interval
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 volunteers
- •BMI between 18.5 and 29.9 kg/m2
- •weighing between 55 and 95 kg
- •willing to use reliable contraception
- •able to give fully informed written consent.
排除标准
- •Pregnant or lactating woman, or sexually active woman of child-bearing potential not using highly effective contraception
- •clinically relevant abnormal medical history, surgery or concurrent medical condition; acute or chronic illness
- •clinically significant QT/QTc interval prolongation at Baseline
- •history of drug-induced or risk factors for Torsade de Pointes
- •any contraindication to moxifloxacin
- •severe adverse reaction to any drug or sensitivity to the trial medication or its components
- •significant food allergy; use of vitamins, herbal medicines, prescription or over-the-counter medication (with the exception of paracetamol [acetaminophen] and oral contraceptives for women) within 20 days or 6 half-lives before first dose of trial medication
- •participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
- •drug or alcohol abuse; smoking of more than 5 cigarettes, 1 cigars or 1 pipes daily
- •regular consumption of more than 5 cups of caffeinated drinks per day
- •positive test for hepatitis A, B & C, HIV
- •objection by a General Practitioner.
研究组 & 干预措施
Imeglimin therapeutic dose
Experimental
Tablet, oral, single dose
干预措施: Imeglimin (Drug)
Imeglimin supratherapeutic dose
Experimental
Tablet, oral, single dose
干预措施: Imeglimin (Drug)
Placebo
Placebo Comparator
Tablet, oral, single dose
干预措施: Placebo (Drug)
Moxifloxacin
Active Comparator
Tablet, oral, single dose (400 mg)
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change from baseline in QTcF (deltaQTcF)
时间窗: Up to 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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