NCT01418963已完成1 期
A Single- and Multiple Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study in Two Single-Center Study Parts to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5285119 Following Oral Administration in Healthy 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
- 77
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults, 18 to 45 years of age (Part 1) or healthy male or female adults, 18 to 65 years of age (Part 2)
- •Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
- •Female subjects must be surgically sterile or postmenopausal
- •Male subjects must use a barrier method of contraception for the duration of the study and for the three months after the last dosing
排除标准
- •History or presence of any significant disease or disorder
- •Positive for hepatitis B. hepatitis C or HIV infection
- •History of drug or alcohol abuse or suspicion of regular consumption of drugs of abuse
- •Participation in an investigational drug or device study within 3 months prior to first dosing
- •Donation of blood within 3 months prior to first dosing
- •Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day)
- •History of hypersensitivity or allergic reactions
- •Part 2: Contraindications for MRI scans
研究组 & 干预措施
Active
Experimental
干预措施: RO5285119 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: up to 5 weeks
次要结局
- Pharmacokinetics: Area under the concentration - time curve (AUC)(up to 5 weeks)
- Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS(up to 5 weeks)
- Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin)(up to 5 weeks)
- Pharmacodynamics: Functional Magnetic Resonance Imaging(up to 5 weeks)
- Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b)(up to 5 weeks)
研究者
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