A Phase 1 Study to Evaluate the Pharmacokinetics of a Tablet Formulation of ABBV-722 and the Effect of Food on Its Bioavailability in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of ABBV-722
研究概览
简要总结
The objective of this study is to evaluate the PK of a tablet formulation of ABBV-722 under fasted conditions and the effect of food on its bioavailability after administration of single doses
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.
- •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.
- •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: Single Dose B
Single dose will be administered under fasted conditions
干预措施: ABBV-722 (Drug)
Period 1: Single Dose A
Single dose will be administered under fasted conditions
干预措施: ABBV-722 (Drug)
Period 2: Single Dose A
Single dose will be administered under fed (high-fat meal) conditions
干预措施: ABBV-722 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of ABBV-722
时间窗: Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Maximum observed plasma concentration (Cmax) of ABBV-722
Time to Cmax (Tmax) of ABBV-722
时间窗: Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Time to Cmax (Tmax) of ABBV-722
Terminal Phase Elimination Rate Constant (β) of ABBV-722
时间窗: Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Terminal phase elimination rate constant of ABBV-722
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
时间窗: Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Terminal phase elimination half-life of ABBV-722
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722
时间窗: Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Area under the plasma concentration-time curve from time 0 to the time of last measurable concentration (AUCt) of ABBV-722
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722
时间窗: Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total)
Area under the plasma concentration-time curve from time 0 to infinite time (AUCinf) of ABBV-722
Number of Participants with Adverse Events (AEs)
时间窗: Up to 57 Days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
未报告次要终点