Assessment of the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of ABBV-903
研究概览
简要总结
The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal, at screening and 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 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.
- •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.
研究组 & 干预措施
Part 1, Sequence B
Participants will receive 1 dose of ABBV-903.
干预措施: ABBV-903 (Drug)
Part 1, Sequence A
Participants will receive 1 dose of ABBV-903.
干预措施: ABBV-903 (Drug)
Part 1, Sequence C
Participants will receive 1 dose of ABBV-903.
干预措施: ABBV-903 (Drug)
Part 2, Sequence B
Participants will receive 1 dose of ABBV-903.
干预措施: ABBV-903 (Drug)
Part 2, Sequence A
Participants will receive 1 dose of ABBV-903.
干预措施: ABBV-903 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of ABBV-903
时间窗: From 0 - 96 hours
Cmax of ABBV-903 will be assessed.
Time to Cmax (Tmax) of ABBV-903
时间窗: From 0 - 96 hours
Tmax of ABBV-903 will be assessed.
Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903
时间窗: From 0 - 96 hours
BETA of ABBV-903 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
时间窗: From 0 - 96 hours
Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903
时间窗: From 0 - 96 hours
AUC0-24 of ABBV-903 will be assessed.
AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903
时间窗: From 0 - 96 hours
AUCt of ABBV-903 will be assessed.
AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903
时间窗: From 0 - 96 hours
AUCinf of ABBV-903 will be assessed.
Number of Participants with Adverse Events
时间窗: Up to 42 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.
次要结局
未报告次要终点