A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- AbbVie
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib
研究概览
简要总结
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 平行分组
- 主要目的
- 基础科学
- 盲法
- 开放（无盲法）
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
- 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.
排除标准
- 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.
研究组 & 干预措施
Arm 1: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily
干预措施: Upadacitinib (Drug)
Arm 3: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily
干预措施: Upadacitinib (Drug)
Arm 2: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily
干预措施: Tofacitinib (Drug)
Arm 5: Multiple doses of Baricitinib
Baricitinib will be administered once daily
干预措施: Baricitinib (Drug)
Arm 4: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib
时间窗: Up to 44 Days
AUC24 of Baricitinib
Number of Participants With Treatment Emergent Adverse Events (TEAE)
时间窗: 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.
Average plasma concentration (Cavg) of Upadacitinib
时间窗: Up to 44 Days
Cavg of Upadacitinib
Average plasma concentration (Cavg) of Tofacitinib
时间窗: Up to 44 Days
Cavg of Tofacitinib
Average plasma concentration (Cavg) of Baricitinib
时间窗: Up to 44 Days
Cavg of Baricitinib
Area under the concentration-time curve over 24 hours (AUC24) of Upadacitinib
时间窗: Up to 44 Days
AUC24 of Upadacitinib
Area under the concentration-time curve over 24 hours (AUC24) of Tofacitinib
时间窗: Up to 44 Days
AUC24 of Tofacitinib
Maximum Observed Plasma Concentration (Cmax) of Upadacitinib
时间窗: Up to 44 Days
Cmax of Upadacitinib
Maximum Observed Plasma Concentration (Cmax) of Tofacitinib
时间窗: Up to 44 Days
Cmax of Tofacitinib
Maximum Observed Plasma Concentration (Cmax) of Baricitinib
时间窗: Up to 44 Days
Cmax of Baricitinib
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07843693
- 其他研究编号
- M26-625
日期
- 首次提交
- (8天前)
- 首次发布
- (前天)
- 主要完成日期
- (2个月后)
- 研究完成日期
- (2个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否