A Phase 1, Open-Label, Single-Dose, Parallel-Cohort Study to Evaluate the Pharmacokinetics of Divarasib in Subjects With Impaired Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Plasma Concentration of Divarasib
研究概览
简要总结
This is a phase 1, open-label, single-dose, parallel-cohort study to determine the pharmacokinetics (PK) of divarasib in healthy participants and participants with varying degrees of hepatic impairment, as defined by Child-Pugh classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 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
Cohort 1
Participants will receive a single oral dose of Divarasib on Day 1.
干预措施: Divarasib (Drug)
Cohort 2
Participants will receive a single oral dose of Divarasib on Day 1.
干预措施: Divarasib (Drug)
Cohort 3
Participants will receive a single oral dose of Divarasib on Day 1.
干预措施: Divarasib (Drug)
Cohort 4
Participants will receive a single oral dose of Divarasib on Day 1.
干预措施: Divarasib (Drug)
结局指标
主要结局
Plasma Concentration of Divarasib
时间窗: Day 1 to Day 7
Maximum Observed Concentration (Cmax) of Divarasib
时间窗: Day 1 to Day 7
Area Under the Concentration-time Curve from Hour 0 to the last measurable concentration (AUC0-t) of Divarasib
时间窗: Day 1 to Day 7
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib
时间窗: Day 1 to Day 7
次要结局
- Percentage of Participants With Adverse Events (AEs)(Up to Week 10)