NCT04953923已完成1 期
A Randomized, Double-blinded, Double-dummy, Placebo-controlled Thorough QTC Study With Single Oral Doses of Cedazuridine in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline in QTcF
研究概览
简要总结
This study is designed to evaluate the effect of therapeutic and supratherapeutic oral doses of cedazuridine on cardiac repolarization, as detected by QTc in healthy subjects, in accordance with regulatory guidelines. Moxifloxacin will be used to validate the study. Study duration per participant is approximately 20 days.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female who is not of childbearing potential
- •Body mass index of 18.0 to 32.0 kg/m^2, inclusive
排除标准
- •QTcF >450 msec at screening
- •Clinically relevant abnormalities in conduction parameters; or if PR interval > 200 msec, QRS duration > 110 msec, or bradycardia or tachycardia (HR <45 bpm or >100 bpm)
- •History or presence of hypokalemia, hypomagnesemia, or hypocalcemia
- •Risk factors for Torsades de Pointes (TdP) (eg, congenital deafness, heart failure, cardiomyopathy, concomitant medications known to cause QTc prolongation) within a washout of at least 30 days
- •Family history of Long QT Syndrome or family history of TdP
- •Sick sinus syndrome, atrioventricular block (any degree)
- •Myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities
- •Repeated or frequent syncope or vasovagal episodes
- •Resuscitated arrest possibly due to TdP; hypertension, angina, or severe peripheral arterial circulatory disorders
- •Use of concomitant medications that prolong the QT/QTc interval
研究组 & 干预措施
Treatment A
Experimental
Cedazuridine at a therapeutic dose
干预措施: Cedazuridine (Drug)
Treatment B
Experimental
Cedazuridine at a supratherapeutic dose
干预措施: Cedazuridine (Drug)
Treatment C
Placebo Comparator
Placebo control
干预措施: Placebo (Drug)
Treatment D
Active Comparator
Moxifloxacin positive control
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change from baseline in QTcF
时间窗: Baseline and Day 20
Change from baseline in QTcF following single therapeutic and supratherapeutic doses of cedazuridine
次要结局
- Pharmacokinetic parameter: Tmax(Up to Day 20)
- Change from baseline in QTcF(Baseline and Day 20)
- Change from baseline in heart rate(Baseline and Day 20)
- Change from baseline in PR interval of the electrocardiogram (ECG)(Baseline and Day 20)
- Change from baseline in T-wave morphology(Baseline to Day 20)
- Safety: Participants with adverse events(Up to Day 20)
- Change from baseline in QRS interval of the electrocardiogram (ECG)(Baseline and Day 20)
- Pharmacokinetic parameter: Cmax(Up to Day 20)
- Pharmacokinetic parameter: AUClast(Up to Day 20)
研究者
研究点 (1)
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