A Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of ABBV-722 and Upadacitinib Following Multiple Oral Doses in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722
研究概览
简要总结
This is a Phase 1 study to investigate safety and pharmacokinetics of ABBV-722 and Upadacitinib following multiple oral doses in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Laboratory values meet the criteria specified in the protocol.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
排除标准
- •History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- •Chronic recurring infection and/or active viral infection.
- •Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
- •Use of tobacco or nicotine-containing products within 90 days prior to the first dose of study drug.
- •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
- •Prior exposure to ABBV-722 within 90 days prior to the first dose of study drug.
研究组 & 干预措施
Period 3: Group 2
Participants will receive multiple doses of ABBV-722 and Upadacitinib
干预措施: ABBV-722 (Drug)
Period 3: Group 2
Participants will receive multiple doses of ABBV-722 and Upadacitinib
干预措施: Upadacitinib (Drug)
Period 3: Group 1
Participants will receive multiple doses of ABBV-722 and Upadacitinib
干预措施: Upadacitinib (Drug)
Period 2: Group 2
Participants will receive multiple doses of ABBV-722
干预措施: ABBV-722 (Drug)
Period 3: Group 1
Participants will receive multiple doses of ABBV-722 and Upadacitinib
干预措施: ABBV-722 (Drug)
Period 1: Group 1
Participants will receive multiple doses of Upadacitinib
干预措施: Upadacitinib (Drug)
Period 1: Group 2
Participants will receive multiple doses of Upadacitinib
干预措施: Upadacitinib (Drug)
Period 2: Group 1
Participants will receive multiple doses of ABBV-722
干预措施: ABBV-722 (Drug)
结局指标
主要结局
Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722
时间窗: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Cmax,ss of ABBV-722
Time to maximum observed plasma concentration (Tmax) of ABBV-722
时间窗: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Tmax of ABBV-722
Area under curve over the dosing interval at steady state (AUCtau,ss) of ABBV-722
时间窗: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
AUCtau,ss of ABBV-722
Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of ABBV-722
时间窗: Up to Day 6 in Period 2 and Up to Day 17 in Period 3
Ctrough,ss of ABBV-722
Maximum observed plasma concentration at steady state (Cmax,ss) of Upadacitinib
时间窗: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Cmax,ss of Upadacitinib
Time to maximum observed plasma concentration (Tmax) of Upadacitinib
时间窗: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Tmax of Upadacitinib
Area under curve over the dosing interval at steady state (AUCtau,ss) of Upadacitinib
时间窗: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
AUCtau,ss of Upadacitinib
Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of Upadacitinib
时间窗: Up to Day 7 in Period 1 and Up to Day 17 in Period 3
Ctrough,ss of Upadacitinib
Area under curve over the dosing interval at steady state (AUCtau,ss) of ABBV-722
时间窗: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
AUCtau,ss of ABBV-722
Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722
时间窗: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Cmax,ss of ABBV-722
Time to maximum observed plasma concentration (Tmax) of ABBV-722
时间窗: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Tmax of ABBV-722
Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of ABBV-722
时间窗: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Ctrough,ss of ABBV-722
Maximum observed plasma concentration at steady state (Cmax,ss) of Upadacitinib
时间窗: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Cmax,ss of Upadacitinib
Time to maximum observed plasma concentration (Tmax) of Upadacitinib
时间窗: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Tmax of Upadacitinib
Area under curve over the dosing interval at steady state (AUCtau,ss) of Upadacitinib
时间窗: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
AUCtau,ss of Upadacitinib
Observed plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of Upadacitinib
时间窗: Up to day 7 in Period 1, up to day 6 in Period 2, up to day 17 in period 3
Ctrough,ss of Upadacitinib
Number of Participants with Adverse Events (AEs)
时间窗: Approximately up to 91 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
未报告次要终点