A Phase 1 Open-Label Drug-Drug Interaction Study Between ABBV-903 and Midazolam
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam 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
- •BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
- •Negative test result for SARS-CoV-2 infection upon initial confinement
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
排除标准
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.
研究组 & 干预措施
Part 1: Period 1
In Period 1 on Day 1, participants will receive liquid midazolam.
干预措施: Midazolam (Drug)
Part 1: Period 2
In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 10, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.
干预措施: ABBV-903 (Drug)
Part 1: Period 2
In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 10, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.
干预措施: Midazolam (Drug)
Part 2: Period 1
In Period 1 on Day 1, participants will receive liquid midazolam.
干预措施: Midazolam (Drug)
Part 2: Period 2
In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 5, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.
干预措施: ABBV-903 (Drug)
Part 2: Period 2
In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 5, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.
干预措施: Midazolam (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 40 days
An 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.
Maximum Plasma Concentration (Cmax) of ABBV-903
时间窗: Up to approximately 40 days
Cmax of ABBV-903
Maximum Plasma Concentration (Cmax) of Midazolam
时间窗: Up to approximately 40 days
Cmax of midazolam
Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam
时间窗: Up to approximately 40 days
Cmax of 1-OH-midazolam
Time to Cmax (Tmax) of ABBV-903
时间窗: Up to approximately 40 days
Tmax of ABBV-903
Time to Cmax (Tmax) of Midazolam
时间窗: Up to approximately 40 days
Tmax of midazolam
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903
时间窗: Up to approximately 40 days
Terminal phase elimination half-life of ABBV-903
Terminal Phase Elimination Half-Life (t1/2) of Midazolam
时间窗: Up to approximately 40 days
Terminal phase elimination half-life of midazolam
Time to Cmax (Tmax) of 1-OH-Midazolam
时间窗: Up to approximately 40 days
Tmax of 1-OH-midazolam
Terminal Phase Elimination Half-Life (t1/2) of 1-OH-Midazolam
时间窗: Up to approximately 40 days
Terminal phase elimination half-life of 1-OH-midazolam
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903
时间窗: Up to approximately 40 days
AUCt of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam
时间窗: Up to approximately 40 days
AUCt of midazolam
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of 1-OH-Midazolam
时间窗: Up to approximately 40 days
AUCt of 1-OH-midazolam
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903
时间窗: Up to approximately 40 days
AUCinf of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam
时间窗: Up to approximately 40 days
AUCinf of midazolam
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of 1-OH-Midazolam
时间窗: Up to approximately 40 days
AUCinf of 1-OH-midazolam
次要结局
未报告次要终点