NCT01371162已完成1 期
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 and in CHC Genotype 1 Infected Patients
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
- 42
- 主要终点
- Parts A + B: Safety: Incidence of adverse events
研究概览
简要总结
This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).
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
- All
- 接受健康志愿者
- 是
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 (no prior antiviral therapy for chronic hepatitis C with interferon-based therapy)
- •Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis
排除标准
- •Pregnant or lactating women, and male partners of women who are pregnant or lactating
- •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 for 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
研究组 & 干预措施
A1 Healthy Volunteers
Experimental
干预措施: RO5428029 (Drug)
A2
Placebo Comparator
干预措施: placebo (Drug)
B1 HCV Infection
Experimental
干预措施: RO5428029 (Drug)
B2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Parts A + B: Safety: Incidence of adverse events
时间窗: up to 24 days
Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)
时间窗: up to 24 days
Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)
时间窗: up to 17 days
次要结局
- Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test(up to 17 days)
研究者
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