NCT01356550已完成1 期
A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838
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
- 35
- 主要终点
- Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax)
研究概览
简要总结
This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18 and 32 kg/m2 inclusive
- •Healthy Subjects:
- •Adult male or female subjects, 18-70 years of age
- •Hepatically impaired patients:
- •Adult patients, 18-65 years of age
- •Documented chronic stable mild/moderate/severe liver disease (Child-Pugh class A, B or C)
- •Hepatic impairment should be primary and must not be a complication of an underlying primary disease
排除标准
- •Pregnant or lactating women
- •Suspicion of drug abuse or addiction at time of screening/Day -1 or history of drug abuse in the last month (patients) or last year (healthy volunteers) prior to Day -1
- •Confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
- •Positive for HIV infection
- •Renal insufficiency
- •Healthy volunteers:
- •History of significant disease, or evidence of disease or condition which could interfere with the study or relapse during or immediately after the study
- •Any history of depressive episodes or treatment with antidepressants
- •Alcohol consumption averaging more than 2 units (16 g) of alcohol for females or 3 units (24 g) for males per day, or positive alcohol breath test at screening/Day -1
- •Positive for hepatitis B and/or hepatitis C infection
- •Hepatically impaired patients:
- •Evidence of unstable clinically significant disease other than impaired hepatic function, or condition or disease which could interfere with the study or relapse during or immediately after the study
- •Episode of acute depression within the last 6 months or current or previous (within the last 6 months) antidepressant treatment
- •Hepatocellular carcinoma or acute hepatic disease caused by infection or drug toxicity
- •Presence of surgically created or transjugular intrahepatic portal systemic shunts
- •Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchyma disorder and/or disease of the liver
研究组 & 干预措施
Healthy subjects
Experimental
干预措施: RO4917838 (Drug)
Hepatic impairment
Experimental
干预措施: RO4917838 (Drug)
结局指标
主要结局
Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax)
时间窗: 22 days
次要结局
- Safety: Incidence of adverse events(29 days)
研究者
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