EUCTR2011-000640-24-NL进行中（未招募）不适用
A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects (Part A), and in Chronic Hepatitis C Genotype 1 Infected Patients (Part B).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive
- •- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg
- •- Female subjects/patients must be surgically sterile or post-menopausal
- •- Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception
- •- For HCV patients:
- •- Hepatitis C genotype 1 of >/= 6 months duration at screening
- •- HCV RNA quantifiable (Roche COBAS TaqMan HCV Test) at screening
- •- HCV treatment-naïve
- •- Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant or lactating women, and male partners of women who are pregnant or lactating
- •- Women with reproductive potential
- •- Positive test for drugs of abuse
- •- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol
- •- History or symptoms of any significant disease or disorder
- •- History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)
- •- Positive for hepatitis B or HIV infection, and/ or HCV for healthy volunteers (Part A)
- •- For HCV patients:
- •- Decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (PTINR) >/= 2.0 at screening
- •- Evidence of cirrhosis and/or incomplete transition to cirrhosis
- •- Presence or history of non-hepatitis C liver disease
研究者
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