An Open-Label, Fixed Sequence, Two-Period Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Period 1: Apparent Total Clearance (CL/F) of Pitavastatin
研究概览
简要总结
The main purpose of the study is to characterize the interaction between RO7049389 and the cholesterol-lowering drug, pitavastatin, in healthy volunteers. There is no intended clinical benefit to this study. The total duration of the study for each participant is approximately 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（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
Pitavastatin
Period 1: Participants will receive a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 and up to 21 days.
Period 2: Participants will receive RO7049389 on Days 1-6. Participants will also receive a single dose of pitavastatin on Day 4.
干预措施: RO7049389 (Drug)
Pitavastatin
Period 1: Participants will receive a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 and up to 21 days.
Period 2: Participants will receive RO7049389 on Days 1-6. Participants will also receive a single dose of pitavastatin on Day 4.
干预措施: Pitavastatin (Drug)
结局指标
主要结局
Period 1: Apparent Total Clearance (CL/F) of Pitavastatin
时间窗: Period 1
Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin
时间窗: Period 1 Day 1
Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
时间窗: Period 1 Day 1
Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin
时间窗: Period 2 Day 4
Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin
时间窗: Period 1 Day 1
Period 1: Elimination Half-Life (T1/2) of Pitavastatin
时间窗: Period 1 Day 1
Period 1: Volume of Distribution (V/F) of Pitavastatin
时间窗: Period 1 Day 1
Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin
时间窗: Period 2 Day 4
Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin
时间窗: Period 2 Day 4
Period 2: Apparent Total Clearance (CL/F) of Pitavastatin
时间窗: Period 2 Day 4
Period 2: Volume of Distribution (V/F) of Pitavastatin
时间窗: Period 2 Day 4
Period 2: Elimination Half-Life (T1/2) of Pitavastatin
时间窗: Period 2 Day 4
次要结局
- Period 2: Cmax of RO7049389(Period 2 Days 3-4)
- Percentage of Participants With Adverse Events (AEs)(From the start of Period 1 through safety follow-up (Period 2, Day 34))
- Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin(Period 1 Day 1)
- Period 2: Cmax of Pitavastatin Lactone(Period 2 Day 4)
- Period 2: AUC0-inf of Pitavastatin Lactone(Period 2 Day 4)
- Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin(Period 2 Day 4)
- Period 2: AUC-tau of RO7049389(Period 2 Days 3-4)
- Period 1: Cmax of Pitavastatin Lactone(Period 1 Day 1)
- Period 1: AUC0-inf of Pitavastatin Lactone(Period 1 Day 1)