A Single Ascending Dose Tolerability and Pharmacokinetic Study of RO5303253 With a Pilot Food-effect Investigation in Healthy Subjects and Exploratory Pharmacokinetic, Pharmacodynamic, and Safety Assessments in Chronic Hepatitis C Genotype 1 Patients Following 5 Days of Oral Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure
研究概览
简要总结
This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.
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 volunteers or patients with chronic hepatitis C genotype 1, 18 to 60 years of age
- •Patients must be treatment-naïve for antiviral therapy for chronic hepatitis C with interferon based therapy
- •Body mass index (BMI) 18 - 32 kg/m2 inclusive, minimum weight 45 kg
- •Females must be surgically sterile or menopausal
- •Male subjects and their partners of childbearing potential must use 2 methods of contraception throughout the study and for 70 days after the last dose
排除标准
- •Pregnant or lactating women and male partners of women who are pregnant or lactating
- •Women with reproductive potential
- •Positive for hepatitis B or HIV (or hepatitis C for healthy volunteers) at screening
- •For hepatitis C patients: decompensated liver disease or impaired liver function, evidence of cirrhosis documented at any time, presence or history of non-hepatitis C chronic liver disease
研究组 & 干预措施
A: HV ascending dose
干预措施: Placebo (Drug)
A: HV ascending dose
干预措施: RO5303253 (Drug)
B: HV food effect
干预措施: Placebo (Drug)
B: HV food effect
干预措施: RO5303253 (Drug)
C: Hepatitis C
干预措施: Placebo (Drug)
C: Hepatitis C
干预措施: RO5303253 (Drug)
结局指标
主要结局
Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure
时间窗: approximately 6 months
Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713
时间窗: approximately 6 months
次要结局
- Effect of food intake on pharmacokinetics in healthy volunteers(Days 1-4)
- Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients(From baseline to Day 15)