A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
- •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 study drug
- •Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study
排除标准
- •Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
- •Is pregnant or breastfeeding
- •Has previously received either IDX719 or simeprevir
- •Has participated in another clinical drug study within 30 days of Screening
研究组 & 干预措施
Group A: IDX719 then IDX719/Simeprevir
Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
干预措施: IDX719 (Drug)
Group A: IDX719 then IDX719/Simeprevir
Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
干预措施: Simeprevir (Drug)
Group B: Simeprevir then IDX719/Simeprevir
Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
干预措施: IDX719 (Drug)
Group B: Simeprevir then IDX719/Simeprevir
Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
干预措施: Simeprevir (Drug)
Group C: IDX719
Healthy participants take IDX719 150 mg QD on Days 1-14.
干预措施: IDX719 (Drug)
Group D: IDX719/Simeprevir
Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK.
干预措施: IDX719 (Drug)
Group D: IDX719/Simeprevir
Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK.
干预措施: Simeprevir (Drug)
Group E: High-Fat then Low-Fat PK
Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout).
干预措施: IDX719 (Drug)
Group F: Low-Fat then High-Fat PK
Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout).
干预措施: IDX719 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 30 days
Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)
时间窗: Up to 30 days
AUC from time zero to infinity
时间窗: Up to 30 days
Trough plasma concentration (Ctrough)
时间窗: Up to 30 days
次要结局
- Percentage of participants experiencing serious adverse events (SAEs)(Up to 30 days)
- Percentage of participants experiencing adverse events (AEs)(Up to 30 days)
- Percentage of participants experiencing Grade 1-4 laboratory abnormalities(Up to 30 days)