A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Observed maximum plasma drug concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also 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
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agrees 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
- •Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug
排除标准
- •Is pregnant or breastfeeding
- •Has another clinically significant medical conditions or laboratory abnormality(s)
研究组 & 干预措施
IDX719 + RTV
Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
干预措施: IDX719 (Drug)
IDX719 + RTV
Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
干预措施: Simeprevir (Drug)
IDX719 + RTV
Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
干预措施: TMC647055 (Drug)
IDX719 + RTV
Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
干预措施: RTV (Drug)
Simeprevir/TMC647055 + RTV
Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
干预措施: IDX719 (Drug)
Simeprevir/TMC647055 + RTV
Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
干预措施: Simeprevir (Drug)
Simeprevir/TMC647055 + RTV
Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
干预措施: TMC647055 (Drug)
Simeprevir/TMC647055 + RTV
Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
干预措施: RTV (Drug)
结局指标
主要结局
Observed maximum plasma drug concentration (Cmax)
时间窗: Up to 14 days
Time to maximum concentration (Tmax)
时间窗: Up to 14 days
Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)
时间窗: Up to 14 days
Predose trough concentration (Ctrough)
时间窗: Up to 14 days
Apparent terminal elimination rate constant
时间窗: Up to 14 days
Observed terminal half-life (T1/2)
时间窗: Up to 14 days
次要结局
- Percentage of participants experiencing serious adverse events (SAEs)(Up to 28 days)
- Percentage of participants experiencing adverse events (AEs)(Up to 28 days)
- Percentage of participants with Grade 1-4 laboratory abnormalities(Up to 28 days)