An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study of the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Renal Function or Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- CLR of Olaparib
研究概览
简要总结
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow eligible study patients continued access to olaparib after the PK phase and will provide additional safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Normal renal function
Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation).
干预措施: Olaparib tablet dosing (Drug)
Mild renal impairment
Patients with calculated serum creatinine clearance 51-80 mL/min (using Cockcroft-Gault equation).
干预措施: Olaparib tablet dosing (Drug)
Moderate renal impairment
Patients with calculated serum creatinine clearance 31-50 mL/min (using Cockcroft-Gault equation).
干预措施: Olaparib tablet dosing (Drug)
结局指标
主要结局
CLR of Olaparib
时间窗: Part A: Day 1, 0-12 hours and 12-24 hours post-dose
Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24
t1/2 of Olaparib
时间窗: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Terminal half-life of olaparib
Cmax of Olaparib
时间窗: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Maximum plasma drug concentration of olaparib
AUC of Olaparib
时间窗: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Area under plasma concentration-time curve from zero to infinity of olaparib
AUC0-t of Olaparib
时间窗: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Area under plasma concentration-time curve from zero to the last measurable time point of olaparib
Tmax of Olaparib
时间窗: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Time to reach maximum plasma concentration of olaparib
Vz/F of Olaparib
时间窗: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Apparent volume of distribution of olaparib
CL/F of Olaparib
时间窗: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Apparent plasma clearance of olaparib
次要结局
未报告次要终点