A Randomised, Partially Double Blind, Placebo and Positive Controlled, 4 Way Crossover Study to Evaluate the Effect of Icosabutate (NST 4016) on the QT/QTc Interval in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
研究概览
简要总结
This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and supratherapeutic doses of icosabutate 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
- Triple (Participant, Care Provider, Investigator)
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
- •Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
- •Body mass index (BMI) between 18.0 and 33.0 kg/m2, inclusive, at Screening
- •In good health
排除标准
- •An uninterpretable or abnormal ECG at Screening and/or Check in
- •History of risk factors for Torsades de Pointes
- •sustained supine systolic blood pressure >140 mmHg or <90 mmHg
- •Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
- •Female subjects who are pregnant (or planning to become pregnant within 90 days after the final dose administration) or are currently lactating
- •Subjects who, in the opinion of the Investigator (or designee), should not participate in this study
研究组 & 干预措施
Placebo oral capsule
Single dose of placebo to match NST-4016
干预措施: Placebo oral capsule (Drug)
Moxifloxacin 400mg
Single 400mg dose of active comparator moxifloxacin (open label)
干预措施: Moxifloxacin 400mg (Drug)
NST-4016 600mg
Likely therapeutic dose of NST-4016
干预措施: NST-4016 600mg (Drug)
NST-4016 2000mg
Supratherapeutic dose of NST-4016
干预措施: NST-4016 2000mg (Drug)
结局指标
主要结局
Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
时间窗: 24 hours
Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)
次要结局
- Change From Baseline in Heart Rate (HR)(24 hours)
- Change From Baseline in Fridericia's Correction for QT Interval (QTcF)(24 hours)
- Change From Baseline in PR Interval (PR)(24 hours)
- Change From Baseline in QRS Interval (QRS)(2 hours)