A Blinded, Randomized, Placebo-Controlled Study in Healthy and HCV Genotype 1-infected Adults, to Evaluate the Safety, Tolerability, Antiviral Activity, Pharmacokinetics (Including the Effect of Food) and Resistance Profile of Single and Multiple Doses of ABT-267
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 137
- 试验地点
- 3
- 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
Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Ascending Dose (SAD)
Healthy volunteers, receiving single ascending doses of ABT-267 or placebo.
干预措施: ABT-267 (Drug)
Single Ascending Dose (SAD)
Healthy volunteers, receiving single ascending doses of ABT-267 or placebo.
干预措施: Placebo (Drug)
Multiple Ascending Dose (MAD)
Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor.
干预措施: ABT-267 (Drug)
Multiple Ascending Dose (MAD)
Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor.
干预措施: Placebo (Drug)
Multiple Ascending Dose (MAD)
Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor.
干预措施: Cytochrome P450 inhibitor (Drug)
Food Effect (FE)
Healthy volunteers, receiving ABT-267, multi-dose, food effect.
干预措施: ABT-267 (Drug)
Antiviral Activity
HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days.
干预措施: ABT-267 (Drug)
Antiviral Activity
HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days.
干预措施: Placebo (Drug)
Resistance Monitoring
HCV genotype 1-infected treatment naïve subjects, receiving at least one dose of ABT-267 or placebo in the "Antiviral Activity" arm, follow-up to monitor resistance developed to ABT-267, no treatment and only blood samples will be collected
干预措施: Blood Sample Collection (Procedure)
结局指标
主要结局
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
时间窗: Up to 15 days or less
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, vital signs, ECGs, continuous cardiac monitoring, and clinical lab results (including chemistry, hematology and urine).
时间窗: Update to 20 days or less
次要结局
未报告次要终点