NCT01185873已完成1 期
The Effect of Hepatic Impairment on the Pharmacokinetics of RO5190591/Ritonavir: A Multiple-Center, Open-Label Study Following Multiple Oral Doses of RO5190591/Ritonavir to Subjects With Mild, Moderate, or Severe Hepatic Impairment and Healthy Subjects With Normal Hepatic Function
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
- 81
- 主要终点
- Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment
研究概览
简要总结
This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. Participants will be administered repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Healthy Volunteers:
- •Adult healthy volunteers, 18-70 years of age
- •Weight >/=50.0 kg
- •Body Mass Index (BMI) 18.0-40.0 kg/m2
- •Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
- •Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
- •Medical history without major recent or ongoing pathology
- •Patients with hepatic impairment:
- •Adult patients, 18-70 years of age
- •Weight >/=50.0 kg
- •Body Mass Index (BMI) 18.0-40.0 kg/m2
- •Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
- •Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
- •Stable, mild, moderate, or severe liver disease of cryptogenic, post-hepatic, hepatitis B or alcoholic origin
排除标准
- •Healthy Volunteers:
- •Pregnant or lactating women and male partners of women who are pregnant or lactating
- •Uncontrolled treated/untreated hypertension (systolic blood pressure >/=160 mmHg and /or diastolic blood pressure >/=105 mmHg
- •Any history of clinically significant cardiovascular or cerebrovascular disease
- •Creatinine clearance </=60 mL/min
- •Positive test results for drugs or alcohol
- •Donation or loss of blood over 450 ml within 60 days prior to screening
- •Patients with hepatic impairment:
- •Pregnant or lactating women and male partners of women who are pregnant or lactating
- •Uncontrolled treated/untreated hypertension (systolic blood pressure >/=160 mmHg and /or diastolic blood pressure >/=105 mmHg
- •Any history of clinically significant cardiovascular or cerebrovascular disease
- •Severe ascites at screening or admission to the clinic
- •History of or current severe hepatic encephalopathy (grade 3 or higher)
- •Any evidence of progressive liver disease within the last 4 weeks
- •History of liver transplantation
- •Creatinine clearance </=60 mL/min
- •Positive test results for drugs or alcohol
- •Donation or loss of blood over 450 ml within 60 days prior to screening
研究组 & 干预措施
1
Experimental
干预措施: danoprevir (Drug)
1
Experimental
干预措施: ritonavir (Drug)
结局指标
主要结局
Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment
时间窗: From baseline to day 10
次要结局
- Safety and tolerability (incidence of adverse events) of danoprevir in patients with hepatic impairment(From baseline to day 10)
研究者
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