Evaluation of the Effects of Sequential Multiple-Dose Regimens of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 4
- 主要终点
- Heart rate-corrected QT interval (QTc)
研究概览
简要总结
This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.
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
- Triple (Participant, 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
- 否
入选标准
- •Men or women, age 18 to 50, inclusive
- •Symptoms of schizophrenia or schizoaffective disorder first appearing a minimum of 1 year before screening
- •Negative pregnancy test
- •Normal physical examination results, vital signs, and clinical lab test results
排除标准
- •Axis II disorder severe enough to interfere with the study
- •Smoking more than 20 cigarettes a day
- •History or presence of cardiovascular disorder
- •Pregnant/breast-feeding and/or planning to become pregnant/breast-feed
- •Imminent risk of injuring self or others or causing significant property damage
研究组 & 干预措施
1
Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine
干预措施: Cariprazine (Drug)
2A
Double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35
干预措施: Risperidone/Moxifloxacin (Drug)
2B
Double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35
干预措施: Risperidone/Moxifloxacin (Drug)
结局指标
主要结局
Heart rate-corrected QT interval (QTc)
时间窗: 35 days of double-blind treatment, up to 56 days total.
The effects of a therapeutic dosage (9 mg/day) and a supratherapeutic dosage (18 mg/day) of cariprazine on cardiac repolarization as determined by heart-rate-corrected QT intervals will be assessed on Day 20 and Day 34, respectively. The assay sensitivity of moxifloxacin 400 mg/day will be assessed on Day 6 and Day 35.
次要结局
未报告次要终点