Evaluation of the Impact of Increased Gastric pH Following Omeprazole Administration on the Absorption of Baricitinib in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib
研究概览
简要总结
The main purpose of this study is to find out how the body will react to a study drug called baricitinib when taken with another drug called omeprazole.
For each participant, this study will include 2 periods in fixed order. The study will last approximately 25 days, not including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Overtly healthy as determined by medical history and physical examination
- •Women not of childbearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history, or menopause
- •Have a body mass index of 18 to 29 kilograms per square meter (kg/m^2), inclusive, at screening
排除标准
- •Have known allergies to baricitinib, omeprazole, related compounds, or any components of the baricitinib or omeprazole formulations, or history of significant atopy
- •Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological (including clotting disorders), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- •Have an absolute neutrophil count (ANC) less than 2 × 10^9 cells per liter (L) [2000 cells/microliter (μL)] at screening or Day -
- •For abnormal values, a single repeat will be allowed
- •Intend to use over-the-counter or prescription medication (including drugs and substances known to alter gastric potential hydrogen (pH), such as proton pump inhibitors or over-the-counter antacid remedies and/or herbal supplements within 14 days prior to dosing and during the study (with the exception of hormone replacement therapy (HRT) and occasional paracetamol, which will be permitted at the discretion of the investigator), or intended use of vitamin supplements from Day 1 until discharge from the clinical research unit (CRU)
- •Have used or intend to use any drugs or substances that are known to be substrates, inhibitors, or inducers of cytochrome P450 3A4 (CYP3A4) within 30 days prior to dosing and throughout the study
- •Are unable to tolerate or unwilling to undergo insertion of a nasogastric pH probe for assessment of gastric pH during the study
研究组 & 干预措施
Baricitinib
Baricitinib - 10 milligram (mg) tablet administered orally, once, on Day 1.
干预措施: Baricitinib (Drug)
Baricitinib + Omeprazole
Baricitinib - 10 mg tablet administered orally, once, on Day 10. Omeprazole - 40 mg capsule administered orally once daily (QD) for 8 days (Days 3 through 10).
干预措施: Baricitinib (Drug)
Baricitinib + Omeprazole
Baricitinib - 10 mg tablet administered orally, once, on Day 10. Omeprazole - 40 mg capsule administered orally once daily (QD) for 8 days (Days 3 through 10).
干预措施: Omeprazole (Drug)
结局指标
主要结局
PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib
时间窗: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib
时间窗: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
时间窗: Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
次要结局
未报告次要终点