NCT01592331已完成1 期
A Single-Center, Randomized, Investigator/Subject-Blind, Single Dose, Placebo-Controlled, Parallel Group Study to Investigate the Pharmacodynamic and Pharmacokinetic Behavior of RO5508887 in Plasma and Cerebral Spinal Fluid Following Oral Administration in Healthy Volunteers
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
- 42
- 主要终点
- Plasma levels of amyloid biomarkers
研究概览
简要总结
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.
Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or placebo. In-unit period is 6 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, 18 to 65 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- •Body mass index (BMI) 18 to 30 kg/m2 inclusive
- •Must agree to use a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study drug
- •Donation of blood over 500 mL within 6 weeks before drug administration
排除标准
- •Concomitant disease or condition or treatment that could interfere with the conduct of the study or would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- •Allergy to lidocaine
- •Suspicion of regular consumption of drug of abuse
- •Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
- •Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
- •Participation in an investigational drug or device study (last administration of study drug or installation of device) within 6 weeks before RO5508887 administration and within 5 mean half-lives of receiving previous investigational drug before RO5508887 administration. In addition, subject cannot participate unless completely recovered from previous invasive or study procedure
- •Donation of blood over 500 mL within 6 weeks before drug administration
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RO5508887
Experimental
干预措施: RO5508887 (Drug)
结局指标
主要结局
Plasma levels of amyloid biomarkers
时间窗: Pre-dose and up to fullow up, 8-12 days post dose
Cerebral spinal fluid levels of amyloid biomarkers
时间窗: Pre-dose and up to 30 hours post-dose
次要结局
- Safety: Incidence of adverse events(approximately 6 months)
- Pharmacokinetics: Plasma and cerebral spinal fluid concentrations of RO5508887 (and metabolites)(Pre-dose and up to 72 hours post-dose)
研究者
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