NCT01711801已完成1 期
A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics of RO5545965 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
- 53
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This randomized, Investigator/Subject-blind, adaptive single-ascending-dose, placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics (including the effect of food), and pharmacodynamics of RO5545965 following oral administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2 doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period of approximately 2 weeks between treatment periods.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
- •Body mass index (BMI) 18 to 30 kg/m2 inclusive
- •Male subjects (whether surgically sterilized or not) with female partners of child-bearing potential must use two forms of contraception, one of which must be a barrier method, for the duration of the study and for 77 days after the last dose
排除标准
- •History or presence of any clinically significant disease or disorder
- •Any condition or disease 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 clinically significant hypersensitivity or allergic drug reactions
- •Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
- •Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Dietary restrictions that would prohibit the consumption of standardized meals
- •Participation in an investigational drug or device study within 90 days prior to screening, as calculated from the follow-up from the previous study
研究组 & 干预措施
Part 1: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Part 1: RO5545965
Experimental
干预措施: RO5545965 (Drug)
Part 2: Food effect
Experimental
干预措施: RO5545965 (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: up to approximately 10 weeks
次要结局
- Pharmacokinetics: Area under the concentration-time curve (AUC)(Pre-dose and up to 48 hours post-dose)
- Effect of food on the pharmacokinetics of single dose RO55459965: Area under the concentration-time curve (AUC)(pre-dose and up to 48 hours post-dose)
- Pharmacokinetics: Maximum plasma concentration (Cmax)(Pre-dose and up to 48 hours post-dose)
- Pharmacodynamics: Prolactin levels(Pre-dose and up to 10 hours post-dose)
研究者
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