Assessment of the Relative Bioavailability of ABBV-932 Formulations in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of ABBV-932
研究概览
简要总结
This study will assess the relative bioavailability and effect of food on pharmacokinetics of ABBV-932 oral administration in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. 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 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), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of any clinically significant sensitivity or allergy to any medication or food.
研究组 & 干预措施
ABBV-932: Arm E
Participants will receive a single dose of ABBV-932 Arm E on day 1 with a high-fat meal.
干预措施: ABBV-932 (Drug)
ABBV-932: Arm G
Participants will receive a single dose of ABBV-932 Arm G on day 1 with a high-fat meal.
干预措施: ABBV-932 (Drug)
ABBV-932: Arm B
Participants will receive a single dose of ABBV-932 Arm B on day 1 under fasting conditions.
干预措施: ABBV-932 (Drug)
ABBV-932: Arm D
Participants will receive a single dose of ABBV-932 Arm D on day 1 with a high-fat meal.
干预措施: ABBV-932 (Drug)
ABBV-932: Arm C
Participants will receive a single dose of ABBV-932 Arm C on day 1 under fasting conditions.
干预措施: ABBV-932 (Drug)
ABBV-932: Arm H
Participants will receive a single dose of ABBV-932 Arm H on day 1 under fasting conditions.
干预措施: ABBV-932 (Drug)
ABBV-932: Arm A
Participants will receive a single dose of ABBV-932 Arm A on day 1 under fasting conditions.
干预措施: ABBV-932 (Drug)
ABBV-932: Arm F
Participants will receive a single dose of ABBV-932 Arm F on day 1 under fasting conditions.
干预措施: ABBV-932 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of ABBV-932
时间窗: Up to approximately 6 days
Cmax of ABBV-932
Time to Cmax (Tmax) of ABBV-932
时间窗: Up to approximately 6 days
Tmax of ABBV-932
Terminal Phase Elimination Rate Constant (Beta) of ABBV-932
时间窗: Up to approximately 6 days
Terminal phase elimination rate constant (beta) of ABBV-932
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
时间窗: Up to approximately 6 days
Terminal phase elimination half-life of ABBV-932
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
时间窗: Up to approximately 6 days
AUCt of ABBV-932
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
时间窗: Up to approximately 6 days
AUCinf of ABBV-932
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 180 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.
次要结局
未报告次要终点