Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 主要终点
- Analysis of safety measures, including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333 in healthy volunteers and the antiviral activity in HCV infected subjects.
详细描述
Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Selection Criteria for Healthy Volunteers:
- •Subject has provided written consent.
- •Subject is in general good health.
- •If female, subject is postmenopausal.
- •If female, subject is not pregnant and is not breast-feeding.
- •Main Selection Criteria for HCV+ Subjects:
- •Subject is HAV-IgM, HBsAg or HIV Ab negative.
- •Subject is HCV genotype 1 with HCV RNA of > 50,000 IU/mL.
- •Subject is excluded if they have previously received antiviral therapy for HCV infection
- •Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment
- •Subjects must have a prior liver biopsy with histology consistent with HCV induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
排除标准
- •See above for main selection criteria
研究组 & 干预措施
1
Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose
干预措施: ABT-333 (Drug)
1
Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose
干预措施: Placebo (Drug)
2
HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID
干预措施: ABT-333 (Drug)
2
HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID
干预措施: Placebo (Drug)
3
Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect
干预措施: ABT-333 (Drug)
结局指标
主要结局
Analysis of safety measures, including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
时间窗: approximately 1 week
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
时间窗: approximately 1 week or less
次要结局
- Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.(approximately 1 week)