Selections of Subjects With Dramatic Changes in Their Cardiac Repolarization Parameters After a Pharmacologic Stimulus Aiming to Collect Their Skin Biopsy and Blood Cells
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf
研究概览
简要总结
The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.
详细描述
An ECG is performed after a dose of sotalol on about 100 healthy subjects in order to identify about 20 extreme responders (10 high responders and 10 non responders) assessed as Delta QTcf compare to baseline. The ECG will be measured and the delta QTcf will be calculated on the 20 selected subjects in a second part of the clinical trial, cross over erythromycin/placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 40 years of age
- •Caucasian origin
- •BMI 19 to 29 kg/m²
- •Informed Consent obtained
- •National Health Security Number
- •Eligible for Phase I as mentioned in the national registry of healthy volunteers
- •For woman: use of an effective contraceptive method
- •Non Inclusion Criteria:
- •Heart Rate < 50 bpm
- •Hypotension with systolic blood pressure< 100 mm Hg.
- •atrioventricular block (PR interval > 200 ms)
- •Known Chronic illness (hepatic, renal or cardiac impairment, etc..)
- •Raynaud's phenomenon
- •Drug known to prolong QT (http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) in the last 7 days.
- •All chronic treatments are forbidden exceptive : oral contraceptives, paracetamol, vitamins and comfort treatment that do not prolong the QT
- •Known family or individual past history of QT prolongation or unexplained syncope
- •(QTcF) > 450 ms
- •QRS interval non assessable on ECG at rest or bundle-branch block, QRS > 100 ms
- •Allergy to macrolide type antibiotics
- •Known allergy to sotalol or lidocaine
- •Positive blood pregnancy test (Inclusion visit)
- •Known abnormal haemostasis
- •Kaliemia< 3.5 mmol/L
- •Magnesemia< 0,7 mmol/L
- •Under exclusion period or participating to another clinical trial on a new medicinal product
- •Creatinin clearance < 80 ml/min (Cockroft and Gault formula)
- •AST-ALT >3x upper normal limit
排除标准
- 未提供
研究组 & 干预措施
Erythromycin
干预措施: Erythromycin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf
时间窗: 1hour and 20 minutes
Delta QTcf is measured at H0, H0+20 minutes, and H0+1h20, on groups' erythromycin and placebo. QTcf may be adjusted based on the pharmacokinetic data to ensure time of the plasmatic pick is used.
次要结局
- Comparison Delta QTcf eryhtromycin-sotalol(over 3 hours)
- Assess the effect of erythromycin Twave morphologie changes(1hour and 20 min)