A Phase 1, Open-label, Drug-drug-interaction Study to Determine the Effect of Rucaparib on the Pharmacokinetics of Oral Rosuvastatin (Arm A) and Oral Contraceptives (Ethinylestradiol and Levonorgestrel) (Arm B) in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 7
- 主要终点
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
研究概览
简要总结
This study will investigate the drug-drug interactions (DDIs) between rucaparib and oral rosuvastatin (Arm A), and between rucaparib and oral ethinylestradiol and levonorgestrel (Arm B), with rucaparib as a perpetrator.
详细描述
This is a Phase 1, open-label, drug-drug-interaction (DDI) study in patients with advanced solid tumor. In Part I, the effects of rucaparib (600 mg twice daily [BID]) on the PK of oral rosuvastatin (Arm A) and the combined oral contraceptives (ethinylestradiol and levonorgestrel; Arm B) will be assessed.
Part I: patients will receive single oral doses of rosuvastatin or oral contraceptives (according to assigned arm) on Day 1 and Day 19. Continuous treatment with rucaparib at 600 mg BID will commence on Day 5 and continue until the end of Part I (Day 23).
Part II (optional): treatment with rucaparib in 28-day cycles may continue (at the discretion of the Investigator) until progression of disease, unacceptable toxicity, or other reason for discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
Arm A - rucaparib and oral rosuvastatin
干预措施: Rucaparib (Drug)
Arm A - rucaparib and oral rosuvastatin
干预措施: Rosuvastatin (Drug)
Arm B - rucaparib and oral contraceptives
干预措施: Rucaparib (Drug)
Arm B - rucaparib and oral contraceptives
干预措施: Oral Contraceptives (Drug)
结局指标
主要结局
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
时间窗: Day 1 to Day 23
AUC up to time infinity, with extrapolation of the terminal phase (AUC0-inf)
次要结局
- Incidence of clinical laboratory abnormalities [Safety and Tolerability](From Day 1 to last patient visit in Part II (approximately 2 years))
- Incidence of dose modifications [Safety and Tolerability](From Day 1 to last patient visit in Part II (approximately 2 years))
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.(Day 1 to Day 23)
- The following secondary PK parameter will be calculated for rucaparib.(Day 1 to Day 23)
- Incidence of Adverse Events [Safety and Tolerability](From Day 1 to last patient visit in Part II (approximately 2 years))