A Randomized, Parallel Group Safety Evaluation of Electrocardiographic Intervals and Blood Pressure in Normal Healthy Volunteers After Nebivolol, Atenolol, Moxifloxacin, or Placebo Administration After Single and Repeated Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7.
研究概览
简要总结
Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and nonpregnant, nonlactating women were 18 years or older.
- •Women declaring postmenopausal or surgical sterility.
- •Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing.
- •Male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). All volunteers weighed within 15% of their ideal body weight (IBW).
排除标准
- •Institutionalized
- •Reported or was known to have done the following:
- •Used any tobacco product.
- •Ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication
- •Consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication.
- •Ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication.
- •Recently changed dietary or exercise habits significantly
- •Used any medication (including over-the-counter [OTC]) within the 14 days prior to the initial dose of study medication.
- •Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- •Received an investigational drug within 30 days prior to the initial dose of study medication.
- •History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
- •History of drug and/or alcohol abuse within 1 year prior to the study.
- •Acute illness at the time of either the pre study medical evaluation or dosing.
- •Any laboratory results deemed clinically significant by the physician.
- •Abnormal and clinically relevant ECG tracing.
- •Donated or lost a significant volume of blood or plasma (>450 mL) within 28 days prior to the initial dose of study medication.
- •Allergic or hypersensitive to nebivolol, atenolol, or other β blocking drugs or to moxifloxacin or other quinolone antibiotics.
- •History of seizures or cerebrovascular disease.
结局指标
主要结局
The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7.
次要结局
- The secondary endpoints were the change in average QTc intervals from Day 0 to all other evaluation times and the change in other ECG intervals (PR, RR, QRS, QT) and HR from Day 0 to all other evaluation times.