Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants

Shenzhen TargetRx, Inc.1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2024年6月26日最近更新: 2025年2月21日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Shenzhen TargetRx, Inc.
入组人数: 6
试验地点: 1
主要终点: Urine radioactivity

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

This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.

详细描述

This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-326 using the Carbon-14 labelled isotope of TGRX-326 compound. Safety evaluation will also be conducted.

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 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy adult males
•Age between 18 and 45 years old (both limits included)
•Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg
•Willing to consent
•Able to communicate with investigator and complete study according to study protocol

排除标准

•Clinically significant results from comprehensive physical and clinical examinations
•Positive results on hepatitis, HIV or syphilis
•Clinically significant results from eye examination
•Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening
•Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements
•Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement
•Presence of any condition that could affect drug absorption
•Reception of major surgery within 6 months before screening, or surgical wounds not completely healed
•Presence of allergic reactions or may be allergic to ingredients in the investigational drug
•Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces
•Habitual congestion or diarrhea
•Alcohol abuse or excessive alcohol consumption within 6 months before screening
•Excessive smoking within 3 months before screening
•Substance abuse or positive results on urine substance test
•Habits of grapefruit juice consumption or excessive caffeinated drinks consumption
•History of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies
•Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness
•Participation in any other clinical studies within 3 months before screening
•Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study
•Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion
•Blood donation or blood loss of > 400 ml within 3 months before screening; blood donation or blood loss of > 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening, or planning to donate blood within 3 months after study completion
•Having special dietary requirements and unable to follow the uniform dietary plan in the study
•Any conditions that the investigator deemed unfit for the study

研究组 & 干预措施

Experimental: TGRX-326

Experimental

healthy subjects will be given 60mg/100uCi[14C]TGRX-326 in suspension

干预措施: [14C]TGRX-326 (Drug)