Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single Dose Selpercatinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
研究概览
简要总结
The main purpose of this study is to determine the effect of selpercatinib on the levels of rosuvastatin in the blood stream in healthy participants. This study also evaluated the safety and tolerability of rosuvastatin when administered in combination with selpercatinib in healthy participants. This study will last up to approximately 26 days excluding screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined by medical evaluation
- •Participant must be Caucasian
- •Body mass index (BMI) within the range of 19.0 to 32.0 kilograms per meter squared (kg/m²)
排除标准
- •Have known allergies to selpercatinib-related compounds or any components of the formulation of selpercatinib, or or rosuvastatin
- •• Have a significant previous or current history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product
- •Have used or are intending to use over-the-counter or prescription medication, including dietary supplements and herbal medications, within 14 days prior to dosing
研究组 & 干预措施
Rosuvastatin + Selpercatinib
Participants received 20 milligram (mg) of rosuvastatin administered orally on Day 1, followed by 20 mg of rosuvastatin coadministered orally with 160 mg of selpercatinib on Day 5.
干预措施: Rosuvastatin (Drug)
Rosuvastatin + Selpercatinib
Participants received 20 milligram (mg) of rosuvastatin administered orally on Day 1, followed by 20 mg of rosuvastatin coadministered orally with 160 mg of selpercatinib on Day 5.
干预措施: Selpercatinib (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
时间窗: Day 1 and Day 5: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours (h) post dose
PK: Cmax of Rosuvastatin was reported.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin
时间窗: Day 1 and Day 5: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h post dose
PK: AUC(0-∞) of Rosuvastatin was reported.
次要结局
未报告次要终点