A Phase I Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 48
- 主要终点
- Safety and tolerability assessment
研究概览
简要总结
A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-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
- •All subjects
- •Subjects are in good general health.
- •Subjects have provided written informed consent form.
- •All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug. HCV Subjects
- •Documented clinical history compatible with chronic hepatitis C without cirrhosis.
- •Treatment-naïve
- •HCV Genotype 1
排除标准
- •All subjects
- •Pregnant or breastfeeding
- •Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
- •Decompensated liver disease
- •Other clinically significant medical conditions or laboratory abnormalities.
研究组 & 干预措施
Group A
Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days
干预措施: IDX21459 (Drug)
Group A
Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days
干预措施: Matching Placebo (Drug)
Group B
HCV subjects genotype 1, IDX21459 capsules, once for 1 day
干预措施: IDX21459 (Drug)
Group C
HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
干预措施: IDX21459 (Drug)
Group C
HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Safety and tolerability assessment
时间窗: up to 35 days
Proportion of subjects experiencing adverse events.
次要结局
- Pharmacokinetic(Up to 120 hours post dose)