An Open-Label Study to Investigate the Effect of Selpercatinib on the Pharmacokinetics of Dabigatran in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran
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 dabigatran in the blood stream and how long it takes the body to remove dabigatran. This study will also look at how safe and well-tolerated of dabigatran when administered in combination with selpercatinib in healthy participants. This study will last approximately 22 to 25 days.
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
- •Overtly healthy males or females, as determined by medical history, physical examination and vital signs.
- •Body mass index (BMI) within the range of 19 to 35 kilograms per meter squared (kg/m²)
- •Male participants are not required to adhere to contraceptive requirements and female participants of childbearing potential must agree to be either remain abstinent or stay in a same sex relationship without sexual relationships with males or must agree to use a highly effective method of contraception and who underwent bilateral salpingectomy. The Female participants not of childbearing potential are not required to use contraception.
排除标准
- •Have a positive pregnancy test at screening or Day -1, where applicable
- •Are planning to become pregnant during the study or within 1 month of study completion
- •Are women who are lactating
- •Have known allergies to selpercatinib- or dabigatran-related compounds or any components of the formulation of selpercatinib or dabigatran, or history of significant atopy
- •Have a history of allergic reactions to medications or food products
- •Have a clinically significant abnormality of blood pressure and/or pulse rate as determined by the investigator
- •Have known bleeding disorder including prior personal or familiar history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder
- •Clinically significant abnormalities on ECG as determined by the investigator or prolongation of the QTcB or QTcF >450 msec on more than 1 ECG obtained during screening only
- •Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of selpercatinib
- •Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have an average weekly alcohol intake that exceeds 21 units per week (males ≤65 years old) and 14 units per week (females); 1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirit(s)
- •Are smokers of more than 10 cigarettes or e-cigarettes, or 3 cigars or 3 pipes, per day
- •Consume excessive amounts of coffee, tea, cola, or other caffeinated beverages per day
研究组 & 干预措施
Dabigatran + Selpercatinib
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) selpercatinib on Day 8.
There was a washout period of 7 days between dosing on Days 1 and 8.
干预措施: Dabigatran (Drug)
Dabigatran + Selpercatinib
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) selpercatinib on Day 8.
There was a washout period of 7 days between dosing on Days 1 and 8.
干预措施: Selpercatinib (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran
时间窗: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdose
PK: Cmax of Dabigatran
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Dabigatran
时间窗: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose
PK: AUC(0-inf) of Dabigatran
次要结局
- PK: Cmax of Selpercatinib(Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose)
- PK: Time of Maximum Observed Drug Concentration (Tmax) of Selpercatinib(Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose)
- PK: AUC(0-inf) of Selpercatinib(Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose)