NCT01636492已完成1 期
Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.
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
- 71
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male healthy volunteer, 18 to 60 years of age inclusive
- •Body mass index (BMI) 19-35 kg/m2 inclusive
- •Supine blood pressure within the normal range of the center and heart rate >/= 40 provided QTcB is <450 ms
- •Subjects must agree to use a barrier method of contraception (e.g. condom) for the duration of the study and for 30 days after study completion
排除标准
- •History or evidence of any clinically significant disease or disorder
- •Clinically significant ECG abnormalities
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Previous treatment with iron for iron deficiency anemia
- •Regular smoker (>10 cigarettes, >3 pipefuls or >3 cigars per day)
- •History of alcohol and/or drug abuse or addiction within the last 2 years before study start
- •Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
- •Participation in a clinical study with an investigational drug within the last three months prior to screening
- •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 investigators or their designee
研究组 & 干预措施
Bitopertin
Experimental
干预措施: bitopertin (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: 17 days
次要结局
- Pharmacokinetics: Area under the concentration-time curve(Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose)
- Pharmacokinetics: Urine concentrations drug/metabolites(Pre-dose and up to 72 hours post-dose)
研究者
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