A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 21
- 主要终点
- Area under plasma-concentration time curve
研究概览
简要总结
This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer.
详细描述
This is a Phase 1, open-label, fixed-sequence study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on drug transporters (metformin, digoxin and rosuvastatin) following multiple dose administration of repotrectinib in patients with advanced cancer harboring ROS1 and NTRK1 Rearrangements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65+ years（65+ Years, 18-64 Years）
- 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
Repotrectinib (TPX-0005)
Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium)
干预措施: TPX-0005 (Drug)
Repotrectinib (TPX-0005)
Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium)
干预措施: Metformin Hydrochloride (Drug)
Repotrectinib (TPX-0005)
Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium)
干预措施: Digoxin (Drug)
Repotrectinib (TPX-0005)
Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium)
干预措施: Rosuvastatin Calcium (Drug)
结局指标
主要结局
Area under plasma-concentration time curve
时间窗: Within 28 days of first cocktail dose
AUC0-t: area under the plasma-concentration time curve from time 0 to time of the last measurable concentration. AUC0-inf: area under the plasma-concentration time curve from time 0 to infinity (if data permit).
Maximum Observed Plasma Concentration
时间窗: Within 28 days of first cocktail dose
Cmax: maximum observed plasma concentration
次要结局
- Evaluate safety and tolerability(Within 28 days of first cocktail dose)
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company