A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
研究概览
简要总结
To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.
详细描述
A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Criteria for Healthy Adults:
- •Informed consent has been obtained
- •Subject is in general good health
- •If female, then postmenopausal
- •If female, then not pregnant
- •If male, must be surgically sterile or both he and the partner must use birth control
- •Body Mass Index is 18 to 29, inclusive
- •Criteria for HCV-infected Adults:
- •Infected with HCV for at least 6 months as shown by either detectable HCV RNA or reactive antibody, or liver biopsy with pathology indicative of HCV infection, or disclosure of a risk factor
- •Subject is infected with HCV genotype 1 with detectable HCV RNA of > 50,000 IU/mL
排除标准
- •Criteria for Healthy Adults:
- •If female, then pregnant or breast feeding
- •Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab
- •Within 6 months of start of study, drug or alcohol abuse and use of nicotine products
- •Alcohol intake within 48 hours prior to study drug administration
- •Criteria for HCV-infected Adults:
- •Need for prescription or over-the-counter medication
- •Child Pugh score > 5 or clinical evidence of cirrhosis
- •No other cause for liver disease other than HCV infection
- •ALT or AST > 4 x ULN
- •Creatinine > ULN
- •Clinically significant abnormal ECG
- •HCV RNA levels above the level of assay quantification
- •TSH values outside normal range
研究组 & 干预措施
1
Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers
干预措施: ABT-072 (Drug)
1
Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers
干预措施: placebo (Drug)
2
HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD
干预措施: ABT-072 (Drug)
2
HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD
干预措施: placebo (Drug)
结局指标
主要结局
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
时间窗: 2 weeks
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: 2 weeks
次要结局
未报告次要终点