Mass Balance Study of [14C] ABBV-903 in Healthy Male Subjects 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
- 7
- 试验地点
- 1
- 主要终点
- Time to Cmax (peak time, Tmax) of ABBV-903
研究概览
简要总结
The purpose of this study is to evaluate the mass balance and safety of [14C] ABBV-903 in healthy male volunteers following a single oral dose administration.
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
- •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 epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, Gilbert's Syndrome, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness
- •History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to study drug administration.
- •Consider fathering a child or donating sperm during the study and for 94 days after study drug administration.
- •Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.
研究组 & 干预措施
ABBV-903
Participants will receive ABBV-903 on Day 1.
干预措施: ABBV-903 (Drug)
结局指标
主要结局
Time to Cmax (peak time, Tmax) of ABBV-903
时间窗: Up to Day 16
Tmax of ABBV-903 will be assessed.
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903
时间窗: Up to Day 16
AUC0-t of ABBV-903 will be assessed.
AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903
时间窗: Up to Day 16
AUC0-inf of ABBV-903 will be assessed.
Maximum observed concentration (Cmax) of ABBV-903
时间窗: Up to Day 16
Cmax of ABBV-903 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
时间窗: Up to Day 16
Terminal phase elimination half-life (t1/2) will be assessed.
Number of Participants with Adverse Events (AEs)
时间窗: Baseline to Day 46
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