Mass Balance Study of [14C] ABBV-552 in Healthy Male Volunteers Following Single Oral Dose Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Renal clearance ABBV-552 (CLr)
研究概览
简要总结
The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-552 in healthy, male volunteers following administration of a single oral dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers in general good health at Screening.
排除标准
- •Considering fathering a child or donating sperm during the study and for 100 days after study drug administration.
研究组 & 干预措施
ABBV-552
Participants will receive ABBV-552 on Day 1.
干预措施: ABBV-552 (Drug)
结局指标
主要结局
Renal clearance ABBV-552 (CLr)
时间窗: Up to approximately 15 days
Renal clearance of ABBV-552 will be assessed.
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 30 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.
Maximum observed concentration (Cmax) of ABBV-552
时间窗: Up to approximately Day 15
Cmax of ABBV-552 will be assessed.
Time to Cmax (peak time, Tmax) of ABBV-552
时间窗: Up to approximately 15 days
Tmax of ABBV-552 will be assessed.
Terminal phase elimination rate constant (λz) of ABBV-552
时间窗: Up to approximately 15 days
Terminal phase elimination rate constant (λz) of ABBV-552 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-552
时间窗: Up to approximately 15 days
Terminal phase elimination half-life (t1/2) of ABBV-552 will be assessed.
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552
时间窗: Up to approximately 15 days
AUCt of ABBV-552 will be assessed.
Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552
时间窗: Up to approximately 15 days
AUCinf of ABBV-552 will be assessed.
Amount of ABBV-552 excreted in the urine over the sampling period (Aeu)
时间窗: Up to approximately 15 days
Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) will be assessed.
Percent of ABBV-552 excreted in the urine
时间窗: Up to approximately 15 days
Percent excreted = 100 × (Aeu/dose).
Amount of ABBV-552 excreted in the feces over the sampling period (Aef)
时间窗: Up to approximately 15 days
Amount of ABBV-552 excreted in the feces over the sampling period (Aef) will be assessed.
Percent radioactivity excreted in the feces
时间窗: Up to approximately 15 days
Percent excreted = 100 × (Aef/dose).
次要结局
未报告次要终点