Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects
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
- PK: Maximum Concentration (Cmax) of Digoxin
研究概览
简要总结
The purpose of this study is to determine the effect of baricitinib on the levels of digoxin in the blood stream and how long it takes the body to remove digoxin. This study will also look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in healthy participants. This study will last approximately 3-4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Are overtly healthy males or females, as determined by medical history and physical examination
- •Women not of child-bearing potential
- •Menopausal women
- •Have a body mass index of 18.0 to 29.0 kilograms per square meter (kg/m^2)
排除标准
- •Women who are lactating
- •Have previously completed or withdrawn from this study or any other study investigating baricitinib
- •Currently enrolled in, have completed or discontinued within the last 90 days from a clinical trial involving an investigational product
- •Have a pulse rate less than 50 beats per minute (bpm) at screening
- •Have a current or recent history (less than 30 days prior to screening and/or less than 45 days prior to Day -1) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
- •Have an absolute neutrophil count less than 2000 cells/microliter (2×10^9/liter) at screening or Day -1
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine
- •Intend to use over-the-counter or prescription medication and/or herbal supplements within 14 days prior to dosing and during the study
- •Have used or intend to use any drugs or substances that are known to be substrates, inducers, or inhibitors of P-glycoprotein (P-gp) within 30 days prior to dosing and throughout the study
- •Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
研究组 & 干预措施
Baricitinib + Digoxin
Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16.
Baricitinib - 10 mg administered orally, QD, on Days 8 through 16.
干预措施: Baricitinib (Drug)
Baricitinib + Digoxin
Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16.
Baricitinib - 10 mg administered orally, QD, on Days 8 through 16.
干预措施: Digoxin (Drug)
结局指标
主要结局
PK: Maximum Concentration (Cmax) of Digoxin
时间窗: Predose up to 24 hours post-dose on Days 7 and 16
PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
时间窗: Predose up to 24 hours post-dose on Days 7 and 16
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin
时间窗: Predose up to 24 hours post-dose on Days 7 and 16
次要结局
- PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin(0 to 24 hours post-dose on Days 7 and 16)
- PK: Renal Clearance (CLr) of Digoxin(Predose to 24 hours post-dose on Days 7 and 16)