A Bioequivalence and Food Effect Study in Healthy Subjects Comparing Baricitinib Suspension and Commercial Tablet Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose
研究概览
简要总结
The purposes of this study are to determine:
- If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms.
- How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.
- The safety and tolerability of baricitinib.
The study has two parts. Individuals will participate in only one part.
Participants will be admitted to the clinical research unit (CRU) and will be discharged from the CRU following the completion of 3 overnight stays.
Each part of this study will last from 8-10 days, not including screening. Follow-up will occur 7 to 14 days after the last dose of baricitinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 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
- •Have a body mass index (BMI) of 18.5 to 29.9 kilograms per meter squared (kg/m²) inclusive, at screening
排除标准
- •Have received live vaccine(s) within 3 months of screening, or intend to during the study
- •Have a current or recent history (less than [<] 30 days prior to screening and/or <45 days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
研究组 & 干预措施
Baricitinib T1 (Part A)
4 mg (milligram) baricitinib suspension test formulation (TF) administered orally (PO) without water following a 10 hour fast. (Baricitinib T1)
干预措施: Baricitinib suspension (Drug)
Baricitinib T2 (Part A)
4 mg baricitinib suspension formulation (TF) administered PO prior to 240 mL water following a 10 hour fast (Baricitinib T2)
干预措施: Baricitinib suspension (Drug)
Baricitinib R (Part A)
4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
干预措施: Baricitinib tablet (Drug)
Baricitinib TF Fasted (Part B)
4 mg baricitinib suspension test formulation (TF) administered after 10 hour fast. (TF fasting)
干预措施: Baricitinib suspension (Drug)
Baricitinib TF Fed (Part B)
4 mg baricitinib suspension TF administered after a high fat meal.(baricitinib TF Fed)
干预措施: Baricitinib suspension (Drug)
结局指标
主要结局
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose
时间窗: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose
PK: AUC(0-∞) of Baricitinib
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose
时间窗: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose
PK: Cmax of baricitinib after a single oral dose
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose
时间窗: Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose
PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng\*hr/mL)
次要结局
未报告次要终点