Randomized, Double-blind (for Clazosentan), Placebo- and Moxifloxacincontrolled, 3-way Cross-over Phase 1 Study to Assess the Effect of Two Intravenous Doses of Clazosentan on the QTc Interval Duration in Healthy Subjects
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
- Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) with its upper limit of the two-sided 95% confidence interval (CI)
研究概览
简要总结
The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General criteria
- •Signed informed consent prior to any study-mandated procedure
- •Body mass index of 18.0-30.0 kg/m2 (inclusive) at Screening
- •Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and on Day -1 of the first Period
- •12-lead ECG: QT interval corrected using Fridericia's formula (QTcF) <450 ms for male subjects and < 470 ms for female subjects, QRS interval < 110 ms, PR interval ≤ 200 ms, and heart rate (HR) ≤ 90 bpm without clinically relevant abnormalities using a 12-lead ECG measured after 5 min in the supine position at Screening and on Day -1 of the first Period
- •Study-specific criteria
- •Women of non-childbearing potential
- •Male subjects must accept to use a condom and not to procreate for the duration of the study and for 3 months thereafter
排除标准
- •General criteria
- •Previous exposure to clazosentan or to moxifloxacin within 3 months prior to Screening
- •Known hypersensitivity to any of clazosentan excipients or to moxifloxacin or any of its excipients
- •Any contraindication to moxifloxacin treatment
- •Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study
- •Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions if considered clinically significant by the investigator
- •Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture)
- •Participation in a clinical study involving study treatment administration within 3 months prior to Screening or in more than 4 clinical studies within 1 year prior to Screening
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
- •Study-specific criteria
- •History or presence of rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, second- or third-degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation)
研究组 & 干预措施
Treatment sequence ABC
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Clazosentan (Drug)
Treatment sequence ABC
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Placebo (Drug)
Treatment sequence ABC
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Moxifloxacin (Drug)
Treatment sequence ACB
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn
干预措施: Clazosentan (Drug)
Treatment sequence ACB
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn
干预措施: Placebo (Drug)
Treatment sequence ACB
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacinn
干预措施: Moxifloxacin (Drug)
Treatment sequence BAC
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Clazosentan (Drug)
Treatment sequence BAC
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Placebo (Drug)
Treatment sequence BAC
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Moxifloxacin (Drug)
Treatment sequence BCA
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Clazosentan (Drug)
Treatment sequence BCA
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Placebo (Drug)
Treatment sequence BCA
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Moxifloxacin (Drug)
Treatment sequence CBA
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Clazosentan (Drug)
Treatment sequence CBA
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Placebo (Drug)
Treatment sequence CBA
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Moxifloxacin (Drug)
Treatment sequence CAB
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Clazosentan (Drug)
Treatment sequence CAB
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Placebo (Drug)
Treatment sequence CAB
Period A: clazosentan Period B: placebo Period C: placebo + moxifloxacin
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) with its upper limit of the two-sided 95% confidence interval (CI)
时间窗: From 1 hour pre-dose to 24 hour after the end of infusion
次要结局
未报告次要终点