A Study to Evaluate the Safety and Pharmacokinetics of Multiple Doses Upadacitinib, Tofacitinib, and Baricitinib in Healthy Adult Volunteers
A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers
This is a Phase 1, open label, five arm study to evaluate the pharmacodynamic effects of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adult participants.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:ABBVIE CALL CENTER
- 电话号码:844-663-3742
- 邮箱:abbvieclinicaltrials@abbvie.com
学习地点
-
-
Illinois
-
Grayslake、Illinois、美国、60030
- 招聘中
- Acpru /Id# 286751
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, Physical Exam (PE), vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
- A female must not be pregnant, or breastfeeding and is not considering becoming pregnant, cryopreserving her eggs or donating eggs during the study or for approximately 30 days after the last dose of study treatment.
Exclusion Criteria:
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster, one or more prior episodes of disseminated herpes simplex (including eczema herpeticum) or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
- History or evidence of active tuberculosis (TB) disease or latent TB infection.
- Participant has prior exposure to upadacitinib, tofacitinib or baricitinib within the past 90 days.
- Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis.
- Participant has used any medications, vitamins and/or herbal supplements within the 2-week period prior to study treatment administration.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Arm 1: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily |
Oral Tablet |
|
实验性的:Arm 2: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily |
Oral Tablet |
|
实验性的:Arm 3: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily |
Oral Tablet |
|
实验性的:Arm 4: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily |
Oral Tablet |
|
实验性的:Arm 5: Multiple doses of Baricitinib
Baricitinib will be administered once daily |
Oral Tablet |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
大体时间:Up to 44 Days
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Upadacitinib
大体时间:Up to 44 Days
|
Cavg of Upadacitinib |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Tofacitinib
大体时间:Up to 44 Days
|
Cavg of Tofacitinib |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Baricitinib
大体时间:Up to 44 Days
|
Cavg of Baricitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Upadacitinib
大体时间:Up to 44 Days
|
AUC24 of Upadacitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Tofacitinib
大体时间:Up to 44 Days
|
AUC24 of Tofacitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib
大体时间:Up to 44 Days
|
AUC24 of Baricitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Upadacitinib
大体时间:Up to 44 Days
|
Cmax of Upadacitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Tofacitinib
大体时间:Up to 44 Days
|
Cmax of Tofacitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Baricitinib
大体时间:Up to 44 Days
|
Cmax of Baricitinib |
Up to 44 Days
|
合作者和调查者
赞助
调查人员
- 研究主任:ABBVIE INC.、AbbVie
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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