A Phase 1 Study To Investigate The Absorption, Metabolism, and Excretion of [14C]-BGB-11417 Following Single Oral Dose Administration in Healthy Male Subjects

BeiGene1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2023年5月22日最近更新: 2025年4月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 6
试验地点: 1
主要终点: Time to Cmax (Tmax) of BGB-11417 in Plasma

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main objective of this study is to determine the mass balance, routes of elimination, and pharmacokinetics of [14C]-BGB-11417 in healthy male participants along with determining the concentrations of radioactivity in plasma, fecal and urinary elimination of total radioactivity.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 是

入选标准

•The participant is judged by the investigator to be in good general health, as determined by no clinically significant findings from medical history, clinical laboratory assessments, vital sign measurements, 12-Lead electrocardiogram (ECG), and physical examination at screening and check-in
•The participant has a body mass index from 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive, at screening
•The participant has normal hepatic function (Note: Participants with Gilbert's syndrome should not be included)
•Participants must be willing to follow contraceptive practices, as applicable, from check-in until 90 days following study drug administration
•Participants must be willing to refrain from donating sperm from check-in until 90 days following study drug administration

排除标准

•The participant has an absolute B-lymphocyte count of <200 cells/μL
•The participant has a medical history of any issues affecting swallowing, absorption, or metabolism, as judged by the investigator
•The participant has a medical history of any problems affecting venous access or bowel/bladder function
•The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening
•The participant is a smoker or has used nicotine or nicotine-containing products within 6 months before the first dose of study drug
•The subject has creatinine clearance of <90 mL/min, calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
•The participant has used any prescription or over-the-counter medications (except acetaminophen [up to 2 grams per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug
•The participant received any treatment with a moderate CYP3A4 inhibitor or strong CYP3A4 inducer within 14 days (or 5 half-lives, whichever is longer) before the first dose of study drug or during the study
•The participant has consumed grapefruit or grapefruit juice, Seville orange or Seville-orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products within 48 hours before the first dose of study drug or during the study
•The participant has a history of alcohol abuse or drug addiction or psychiatric disorders including major depression disorder within the last year or excessive alcohol consumption (regular alcohol intake >21 units per week) (1 unit is equal to approximately one-half pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits
•The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
•The participant is involved in strenuous activity or contact sports within 24 hours before the first dose of study drug or during the study
•Note: Other inclusion/exclusion criteria may apply

研究组 & 干预措施

[14C] radiolabeled BGB-11417

Experimental

Participants will receive a single dose of [14C]-BGB-11417

干预措施: [14C]-BGB-11417 (Drug)