NCT01873508已完成1 期
A Single-center, Open Label, Randomized Cross-over Study to Compare 3 Modified-release Formulations With Different Release Profiles of RO4917523 Along With a Reference Intravenous Microdose Infusion
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Pharmacokinetics: Area under the concentration-time curve (AUC)
研究概览
简要总结
This single-center, open label, randomized, 3-period cross-over study will compare 3 modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized to one of six sequences to receive single oral doses of RO4917523 slow, target and fast release modified release (MR) capsules along with a reference intravenous microdose with the target capsule. A washout period of at least 21 days will occur between treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers, 18 - 55 years of age inclusive Healthy status will be defined by absence in evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- •Body mass index (BMI) of 18 to 30 kg/m2, inclusive, and body weight of at least 50 kg
- •Females of child-bearing potential must agree to use effective contraception as defined by protocol
- •Non-smoker for at least 90 days prior to dosing on Day 1
排除标准
- •History or presence of a clinically significant psychiatric condition as defined by protocol
- •Participation in an clinical study with an investigational drug within 60 days or 5 times the half-life (whichever is longer) preceding first administration of study drug. Participation in more than 3 other drug studies within 10 months preceding first administration of study drug.
- •Clinically significant disease or disorder
- •Personal or family history of long QT syndrome or sudden death
- •Any suspicion or history of alcohol and/or other substance abuse or dependence in the last 6 months
- •Subject likely to need concomitant medication during the study (including for dental conditions), except for hormonal contraception or HRT
- •Pregnant or lactating women, or women who intend to become pregnant during the course of the study
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Any confirmed significant allergic reactions against any drug, or multiple allergies
研究组 & 干预措施
Fast release MR capsule
Experimental
干预措施: RO4917523 (Drug)
Slow release MR capsule
Experimental
干预措施: RO4917523 (Drug)
Target release MR capsule
Experimental
干预措施: RO4917523 (Drug)
结局指标
主要结局
Pharmacokinetics: Area under the concentration-time curve (AUC)
时间窗: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Maximum concentration (Cmax)
时间窗: Pre-dose and up to 144 hours post-dose
次要结局
- Pharmacokinetics: Time to maximum plasma concentration (tmax)(Pre-dose and up to 144 hours post-dose)
- Safety: Incidence of adverse events(approximately 13 weeks)
- Pharmacokinetics: Absolute bioavailability (F)(Pre-dose and up to 144 hours post-dose)
- Pharmacokinetics: Elimination half-life (t1/2)(Pre-dose and up to 144 hours post-dose)
- Pharmacokinetics: Elimination rate constant: (kel)(Pre-dose and up to 144 hours post-dose)
- Pharmacokinetics: Total body clearance (CL)(Pre-dose and up to 144 hours post-dose)
- Pharmacokinetics: Volume of distribution (Vd)(Pre-dose and up to 144 hours post-dose)
研究者
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