A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-BGB-16673 Following a Single Oral Dose in Healthy Male Participants
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
- Total Radioactivity Recovery (fet1-t2) in Urine and Feces
研究概览
简要总结
The purpose of this study is to determine the absorption, metabolism, and excretion of [14C]-BGB-16673 and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces in healthy male participants following a single oral 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
- Treatment
- 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 between 18.0 and 32.0 kg/m², inclusive.
- •Good health, as determined by no clinically significant findings from medical history.
- •History of a minimum of 1 bowel movement per day.
- •Able to comprehend and are willing to sign the Informed Consent Form (ICF) and abide by the study restrictions.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- •Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, or pulse rate >100 or <40 beats per minute.
- •Alcohol consumption of >21 units per week for males.
- •Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
- •Ingestion of caffeine-containing foods or beverages within 48 hours of check-in or intend to ingest caffeine-containing foods or beverages until end of study.
- •Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in.
- •Ingestion of Seville orange- or grapefruit-containing foods or beverages within 7 days prior to check-in.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Single Arm: [14C]-BGB-16673
Participants will receive a single dose of [14C]-BGB-16673
干预措施: [14C]-BGB-16673 (Drug)
结局指标
主要结局
Total Radioactivity Recovery (fet1-t2) in Urine and Feces
时间窗: Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673
时间窗: Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) for Total Radioactivity in Plasma and Whole Blood
时间窗: Approximately 35 Days
Maximum Observed Plasma Concentration (Cmax) of BGB-16673
时间窗: Approximately 35 Days
Maximum Observed Plasma Concentration (Cmax) for Total Radioactivity in Plasma and Whole Blood
时间窗: Approximately 35 Days
Urinary recovery of BGB-16673 (fet1-t2)
时间窗: Approximately 35 Days
Quantitative metabolic profiles of BGB-16673 in plasma and excreta
时间窗: Approximately 35 Days
Identification of BGB-16673 major metabolites in plasma and excreta
时间窗: Approximately 35 Days
Time of the Maximum Observed Plasma Concentration (Tmax) of BGB-16673
时间窗: Approximately 35 Days
Time of the Maximum Observed Plasma Concentration (Tmax) for Total Radioactivity in Plasma and Whole Blood
时间窗: Approximately 35 Days
Apparent Terminal Elimination Half-life (t1/2) of BGB-16673
时间窗: Approximately 35 Days
Apparent Terminal Elimination Half-life (t1/2) for Total Radioactivity in Plasma and Whole Blood
时间窗: Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673
时间窗: Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) for Total Radioactivity in Plasma and Whole Blood
时间窗: Approximately 35 Days
次要结局
- Number of Participants with Adverse Events (AEs)(Approximately 35 days)
- Number of Participants with Clinically Significant Laboratory Values(Approximately 9 weeks)
- Number of Participants with Clinically Significant Electrocardiogram (ECG) Results(Approximately 9 weeks)
- Number of Participants with Clinically Significant Vital Sign Measurements(Approximately 9 weeks)