A Phase Ia and Ib Dose-Ranging Study to Assess the Safety, Pharmacokinetics, and Antiviral Efficacy of PPI-383 in Healthy Adults and Hepatitis C Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Safety and tolerability, as measured by clinical adverse events and laboratory assessments
研究概览
简要总结
PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the dose-related safety and tolerance of PPI-383 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-383 is absorbed into the bloodstream. In Part II, the dose-related effect of PPI-383 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.
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
- Triple (Participant, Care Provider, Investigator)
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
PPI-383 multiple dose escalation in HCV Subjects
Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients
干预措施: PPI-383 (Drug)
PPI-383 single dose escalation in healthy volunteers
There will be up to 10 sequential single dose cohorts to assess the bioavailability of different doses and formulations; a food effect cohort will be included.
干预措施: PPI-383 (Drug)
PPI-383 single dose escalation in healthy volunteers
There will be up to 10 sequential single dose cohorts to assess the bioavailability of different doses and formulations; a food effect cohort will be included.
干预措施: Placebo (Drug)
PPI-383 multiple doses in healthy volunteers
Upon completion of the single dose cohorts, an additional cohort will receive the highest well-tolerated dose from the single dose cohorts or placebo once daily for five days; up to additional cohorts may receive multiple doses of different formulations or different regimens
干预措施: PPI-383 (Drug)
PPI-383 multiple doses in healthy volunteers
Upon completion of the single dose cohorts, an additional cohort will receive the highest well-tolerated dose from the single dose cohorts or placebo once daily for five days; up to additional cohorts may receive multiple doses of different formulations or different regimens
干预措施: Placebo (Drug)
PPI-383 multiple dose escalation in HCV Subjects
Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability, as measured by clinical adverse events and laboratory assessments
时间窗: Part I, up to day 12; and Part II, up to day 17
次要结局
- PPI-383 plasma levels(Part I, up to day 12; and Part II, up to day 17)
- serum HCV RNA levels(Part II, up to day 17)