NCT01629368已完成1 期
A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Pharmacokinetics: Area under the concentration time curve
研究概览
简要总结
This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, 18-65 years of age inclusive
- •Non-smokers
- •Body mass index (BMI) between 18 and 30 mg/m2 inclusive
- •Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception
排除标准
- •Evidence of any active or chronic disease
- •History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
- •History or presence of clinically significant psychiatric condition
- •Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study
研究组 & 干预措施
Dosing Period 2
Experimental
干预措施: Carbamazepine (Drug)
Dosing Period 1
Experimental
干预措施: RO4917523 (Drug)
Dosing Period 2
Experimental
干预措施: RO4917523 (Drug)
结局指标
主要结局
Pharmacokinetics: Area under the concentration time curve
时间窗: Period 1: Pre-dose and up to Day 14, Period 2: Pre-dose and up to Day 29
次要结局
- Safety: incidence of adverse events(6 weeks)
研究者
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