NCT01345942已完成1 期
A Randomized, Open Label, Single Dose, Two Period, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of RO5428029 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
- 12
- 主要终点
- Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration
研究概览
简要总结
This open label, two period, crossover study will evaluate the safety and the effect of food on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy subjects will be randomized to receive a single oral dose of RO5428029 with or without food, with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days after last dose. Anticipated time on study will be up to 21 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, 18 to 60 years of age inclusive
- •Body mass index (BMI) between 18 and 29.9 kg/m2, inclusive, and a minimum weight of 45 kg
- •Female subjects must be surgically sterile or post-menopausal
- •Male subjects and their partners of child-bearing potential must use 2 methods of contraception (one of which a barrier method) for the duration of the study and for at least 70 days after the last dose
排除标准
- •Pregnant or lactating women, and male partners of women who are pregnant or lactating
- •Women with reproductive potential
- •History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average; alcohol consumption will be prohibited at least 48 hours before screening
- •Positive test for drugs of abuse
- •History or symptoms of any significant disease
- •Positive for HIV, hepatitis B or hepatitis C infection
- •Participation in an investigational drug or device study within 3 months prior to screening
研究组 & 干预措施
A food
Experimental
干预措施: RO5428029 (Drug)
B without food
Experimental
干预措施: RO5428029 (Drug)
结局指标
主要结局
Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration
时间窗: 72 hours
次要结局
- Safety: Incidence of adverse events(approximately 3 weeks)
研究者
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