NCT01457664已完成1 期
A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of RO4995819 Following Oral Administration in Healthy Elderly Subjects.
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
- 30
- 主要终点
- Safety (incidence of adverse events)
研究概览
简要总结
This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteer, 65-85 years of age
- •Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive and a total body weight >50 kg (110 lbs)
- •Able to participate and willing to give written informed consent and to comply with the study restrictions
排除标准
- •Any history or suspicion of drug or alcohol abuse
- •Clinically significant or unstable cardiovascular or bronchopulmonary diseases, or any type of cancer
- •History of liver disease
- •Significant past or present neurological disorder
- •History of psychiatric disorders
- •Participation in an investigational drug or device study within 12 weeks prior to screening
- •Donation of blood over 500 mL within three months prior to screening
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RO4995819
Experimental
干预措施: RO4995819 (Drug)
结局指标
主要结局
Safety (incidence of adverse events)
时间窗: 8 weeks
次要结局
- Pharmacokinetics: area under the concentration time curve (AUC)(Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 22, 20, 36, 62)
研究者
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