NCT07513207已完成1 期
Thorough QT Study to Evaluate the Effects of Single Doses of Vicadrostat on Cardiac Safety Parameters in Healthy Male and Female Subjects (a Randomized, Placebo-controlled, Double-blind, Five-period Crossover Study With Open-label Moxifloxacin as Positive Control)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The maximum mean difference between each single dose of either low or high dose of vicadrostat and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration
研究概览
简要总结
The main objective of this trial is to investigate the effect of vicadrostat on the heart compared with placebo in healthy male and female volunteers.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 50 years (inclusive)
- •Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.
排除标准
- •Any finding in the medical examination (including BP, PR or ECG deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
研究组 & 干预措施
Treatment 1 - vicadrostat low dose
Experimental
干预措施: Vicadrostat (Drug)
Treatment 2 - vicadrostat high dose
Experimental
干预措施: Vicadrostat (Drug)
Treatment 3 - moxifloxacin
Active Comparator
干预措施: Moxifloxacin (Drug)
Treatment 4 - placebo
Placebo Comparator
干预措施: Placebo matching Vicadrostat (Drug)
结局指标
主要结局
The maximum mean difference between each single dose of either low or high dose of vicadrostat and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration
时间窗: at baseline, up to 24 hours
QT interval is the electrocardiogram (ECG) interval from the start of the QRS complex to the end of the T wave QTcF: QT interval corrected for heart rate using the method of Fridericia
次要结局
- The maximum mean difference between moxifloxacin and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration(at baseline, up to 24 hours)
研究者
研究点 (1)
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