NCT01631422已完成1 期
Single-Center, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Radio-labeled RO4602522 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
- 6
- 主要终点
- Pharmacokinetics: Plasma concentration of RO4602522/metabolite
研究概览
简要总结
This single-center, open-label study will investigate the pharmacokinetics and elimination of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers will receive a single oral dose of RO4602522.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, 35 to 55 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 electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
- •A body mass index (BMI) between 18 to 30 kg/m2 inclusive
- •Male volunteers and their partners of childbearing potential must use 2 methods of contraception, one of which must be a barrier method for the duration of the study and for 90 days after the last dose.
- •Able to participate and willing to give written informed consent and to comply with the study restrictions.
- •Non-smokers or have not smoked since at least 3 months prior to screening
排除标准
- •If capable of reproduction, unwilling to use an effective form of contraception
- •Suspicion of regular consumption of drug of abuse and/or positive drug or alcohol screen
- •Infection with hepatitis B, hepatitis C, or human immunodeficiency virus 1 and 2
- •Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg
- •Resting pulse rate greater than 90 or less than 45 beats per minute
- •Clinically significant abnormalities in laboratory test results
- •Participation in an investigational drug or device study within 90 days prior to screening
- •Donation of blood within 3 months prior to screening
- •Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
研究组 & 干预措施
Single Arm
Experimental
干预措施: RO4602522 (Drug)
结局指标
主要结局
Pharmacokinetics: Plasma concentration of RO4602522/metabolite
时间窗: Predose, Day 1, 2 and 3
Pharmacokinetics: Elimination of RO4602522: urine/feces concentration
时间窗: Predose, Day 1, 2 and 3
次要结局
- Pharmacokinetics: Metabolic profile of RO4602522: plasma/urine/feces concentration(Predose, Day 1, 2 and 3)
研究者
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