Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-CLS-7262 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
- •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.
- •Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.
排除标准
- •Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations.
- •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, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •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
[14C] ABBV-CLS-7262
Participants will receive [14C] ABBV-CLS-7262 on Day 1.
干预措施: [14C] ABBV-CLS-7262 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Up to approximately Day 15 from last dose
Cmax will be assessed.
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 30 days from last dose.
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.
Terminal phase elimination half-life (t1/2)
时间窗: Up to approximately 15 days from last dose
Terminal phase elimination half-life (t1/2) will be assessed.
Time to Cmax (peak time, Tmax)
时间窗: Up to approximately 15 days from last dose
Tmax will be assessed.
Percent radioactivity excreted
时间窗: Up to approximately 15 days from last dose
Percentage total radioactivity
Identification of metabolites excreted
时间窗: Up to approximately 15 days from last dose
Identification of the major metabolites
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)
时间窗: Up to approximately 15 days from last dose
AUCt will be assessed.
次要结局
未报告次要终点