A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of LC350189 on the QTc (Corrected QT) Interval in Healthy Adult Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- The placebo-corrected change from baseline in QTcF
研究概览
简要总结
This is a Phase 1, single-center, randomized, partially double-blind, placebo- and positive controlled, 4-way crossover study to evaluate the effect of a therapeutic and a supratherapeutic dose of LC350189 on the QTcF in healthy male and female subjects.
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
- Double (Participant, Investigator)
盲法说明
LC350189 and placebo will be administered in a double blind, double-dummy manner. Moxifloxacin will be administered open-label.
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
- •The subject is 18 to 55 years of age, inclusive, with a body mass index (BMI) 18 to 33 kg/m2, inclusive, at screening.
- •The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
- •The subject is able to provide written informed consent and agrees to comply with all protocol requirements.
排除标准
- •The subject has a history of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, or angina.
- •The subject has a family history of long QT syndrome, Brugada syndrome, or sudden death.
- •The subject has a resting HR of <40 bpm or >100 bpm when vital signs are measured at screening or check-in.
- •The subject has history or presence of unstable cardiovascular disease, including myocardial infarction, cardiac arrhythmia, or cerebrovascular disease (eg, cerebrovascular accident/stroke or transient ischemic attack).
- •The subject has a history of other acute or chronic cardiovascular disease or coronary revascularization surgery (eg, coronary artery bypass graft, percutaneous transluminal coronary angioplasty).
- •The subject uses a cardiac pacemaker.
- •The subject has a history of any other medical, psychological, or social condition that, in the opinion of the investigator or the medical monitor, would prevent the subject from fully participating in the study, would represent a concern for study compliance, or would constitute a safety concern to the subject.
研究组 & 干预措施
Treatment T (Therapeutic dose)
Single oral dose of 200 mg LC350189 (1 × 200 mg tablet) and 2 × placebo tablets.
干预措施: LC350189 200mg (Drug)
Treatment ST (Supratherapeutic dose)
Single oral dose of 600 mg LC350189 (3 × 200 mg tablets).
干预措施: LC350189 600mg (Drug)
Treatment P (Placebo)
Single oral dose of 3 × placebo tablets.
干预措施: Placebo (Drug)
Treatment M (positive control)
Single oral dose of moxifloxacin 400 mg (1 × 400 mg tablet; open label)
干预措施: Moxifloxacin 400mg (Drug)
结局指标
主要结局
The placebo-corrected change from baseline in QTcF
时间窗: Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period
QTcF will be analyzed using concentration-QT (cQT) modeling
次要结局
- The placebo-corrected change from baseline in HR (heart rate)(Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period)
- The placebo-corrected change from baseline in PR(Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period)
- The placebo-corrected change from baseline in QRS(Before dosing (Baseline) through 24 hours after the dose on Day 1 in each treatment period)