NCT07760246招募中1 期
A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Parallel Group Design Trial With Moxifloxacin as Positive Control in a Nested Crossover to Evaluate the Effects of Multiple Doses of Verducatib (BI 1291583) on Cardiac Safety Parameters in Healthy Male and Female Trial Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- QT-interval corrected for heart rate, e.g. using the method of Fridericia change from baseline (ΔQTcF), paired with the verducatib plasma concentrations
研究概览
简要总结
The main objective of this trial is to evaluate the effects of verducatib in the range of therapeutic to supra-therapeutic exposures on the QT/QTc-interval and other ECG parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 and female trial participants
- •Aged 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 blood pressure (BP), heart rate (HR) or electrocardiogram (ECG), deviating from normal and assessed as clinically relevant by the Investigator
- •Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or pulse rate (PR) outside the range of 50 to 90 bpm
- •Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance, including but not limited to increased hepatic parameters, electrolyte disturbances, particularly hypokalemia and hypomagnesemia
- •Any evidence of a concomitant disease assessed as clinically relevant by the Investigator Further exclusion criteria apply.
研究组 & 干预措施
Moxifloxacin placebo followed by Verducatib followed by Moxifloxacin placebo
Experimental
干预措施: Placebo resembling Moxifloxacin (Drug)
Moxifloxacin placebo followed by Verducatib followed by Moxifloxacin placebo
Experimental
干预措施: Verducatib (Drug)
Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin
Experimental
干预措施: Placebo resembling Verducatib (Drug)
Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo
Experimental
干预措施: Placebo resembling Moxifloxacin (Drug)
Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin
Experimental
干预措施: Moxifloxacin (Drug)
Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo
Experimental
干预措施: Moxifloxacin (Drug)
Moxifloxacin followed by Verducatib placebo followed by Moxifloxacin placebo
Experimental
干预措施: Placebo resembling Verducatib (Drug)
Moxifloxacin placebo followed by Verducatib placebo followed by Moxifloxacin
Experimental
干预措施: Placebo resembling Moxifloxacin (Drug)
结局指标
主要结局
QT-interval corrected for heart rate, e.g. using the method of Fridericia change from baseline (ΔQTcF), paired with the verducatib plasma concentrations
时间窗: Up to day 31
ΔQTcF defined as the time-matched QTcF change from baseline, paired with the verducatib plasma concentrations collected at the same timepoints up to a maximum of 30 days after first drug administration of verducatib/verducatib-placebo
次要结局
- QT-interval corrected for heart rate, e.g. using the method of Fridericia change from baseline (ΔQTcF), paired with the moxifloxacin plasma concentrations(Up to day 31)
研究者
研究点 (2)
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