NCT01152671已完成1 期
A Multiple Center Randomized, Double-Blind, Single-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics Following Oral Administration of RO5024048 in Healthy Japanese and Caucasian 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
- 97
- 主要终点
- Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s)
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10 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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults, 20 to 55 years of age, inclusive
- •Body mass index (BMI) 18 - 30 kg/m2 inclusive
- •Non-smoker, or previous smoker who discontinued smoking >/= 6 month prior to study entry
- •Japanese subjects must be first generation: born in Japan, not having lived outside Japan >5 years, able to trace maternal and paternal Japanese ancestry
- •Female subjects of childbearing potential and male subjects and their partners of childbearing potential must agree to use two forms of contraception
- •Agree to abstain from alcohol consumption and from strenuous exercise up to 3 days before dosing and throughout study (including the follow-up visit)
排除标准
- •Positive pregnancy test
- •Males whose female partner is pregnant or trying to become pregnant
- •Positive urine test for drugs of abuse
- •Positive for alcohol
- •Positive result on hepatitis B, hepatitis C, or HIV test
- •Clinically significant disease or abnormalities in laboratory parameters
- •Participation in an investigational drug, biologic or device study within 3 months before study drug administration
- •Donation or loss of any blood over 450 mL within 3 months before study drug administration
研究组 & 干预措施
Arm 1
Experimental
干预措施: RO5024048 (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s)
时间窗: Day 1 to Day 4
次要结局
- Safety and tolerability: Adverse events, laboratory parameters, ECG(Day 1 to Day 10)
研究者
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