Mass Balance Study of [14C] ABBV-1354 (Icalcaprant) 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
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants are eligible to participate if they agree to the following from Study Day 1 and for at least 93 days after the last dose of study treatment:
- •Refrain from donating sperm
- •PLUS, either:
- •- Practice true abstinence, defined as: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
- •Use a male condom with spermicide (even with a successful vasectomy) with female partner who also uses a highly effective contraceptive method with a failure rate of < 1% per year (when used consistently and correctly).
- •Advise of the benefit for a female partner to use a highly effective method of contraception (as a condom may break or leak) if having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- •BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. 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), endocrine, metabolic, 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.
- •History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
研究组 & 干预措施
ABBV-1354
Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose.
干预措施: ABBV-1354 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 32 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.
Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements
时间窗: Up to approximately 15 days
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Change From Baseline in Electrocardiograms (ECGs)
时间窗: Up to approximately 15 days
12-lead resting ECG will be recorded.
Number of Participants with Abnormal Change in Physical Examinations
时间窗: Up to approximately 15 days
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
时间窗: Up to approximately 15 days
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Maximum observed concentration (Cmax) of ABBV-1354
时间窗: Up to approximately 15 days
Cmax of ABBV-1354 will be assessed.
Time to Cmax (peak time, Tmax) of ABBV-1354
时间窗: Up to approximately 15 days
Max of ABBV-1354 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-1354
时间窗: Up to approximately 15 days
Terminal phase elimination half-life (t1/2) of ABBV-1354 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-1354
时间窗: Up to approximately 15 days
AUCt of ABBV-1354 will be assessed.
Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-1354
时间窗: Up to approximately 15 days
AUCinf of ABBV-1354 will be assessed.
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu)
时间窗: Up to approximately 15 days
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.
Percent of ABBV-1354 excreted in the urine
时间窗: Up to approximately 15 days
Percent excreted = 100 × (Aeu/dose).
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu)
时间窗: Up to approximately 15 days
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.
Percent of ABBV-1354 radioactivity excreted in the feces
时间窗: Up to approximately 15 days
Percent excreted = 100 × (Aeu/dose).
次要结局
未报告次要终点