A Single Center, Randomized, Single Dose, Open-label, Four Period Cross-over Study to Investigate the Relative Bioavailability of RO4917838 and the Effect of Food Following Oral Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Effect of high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC)
研究概览
简要总结
This single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers. Subjects will receive in randomized order single oral doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838 hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days between treatments. Anticipated time on study will be up to 23 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers, 18 to 65 years of age, inclusive
- •Body mass index (BMI) 18 to 30 kg/m2 inclusive
- •Healthy as determined by the Investigator on the basis of medical and surgical history and a complete physical examination
- •Non-smoker or smoker of fewer than 10 cigarettes per day; subject must be able to refrain from smoking during the in-patient stays
- •Females who are not postmenopausal or surgically sterile must agree to use two adequate methods of contraception as defined by protocol during the treatment period and for at least one month after the last dose of study drug
排除标准
- •Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
- •History of alcoholism, drug abuse and/or drug addiction within the last year prior to Period
- •Day -1 of the study
- •History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
- •Any history of depressive episodes or treatment with antidepressants
- •Any significant allergic reactions against any drug, or multiple allergies in the judgement of the Investigator
- •Pregnant or lactating females
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Participation in another investigational study of any type within 90 days of RO4917838 administration or within 6 times the elimination half-life of the tested drug, whichever is longer
研究组 & 干预措施
A: film coated tablets, fasted condition
干预措施: RO4917838 (Drug)
B: film coated tablets, fed condition
干预措施: RO4917838 (Drug)
C: hard gelatin capsules
干预措施: RO4927838 (Drug)
D: oral suspension
干预措施: RO4917838 (Drug)
结局指标
主要结局
Effect of high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC)
时间窗: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve
时间窗: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT
时间窗: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
次要结局
- Safety: Incidence of adverse events(approximately 2 months)