Mass Balance Study of [14C] LPM3770164 in Healthy Participants

Luye Pharma Group Ltd.1 个研究点分布在 1 个国家目标入组 8 人开始时间: 2026年4月30日最近更新: 2026年4月8日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Luye Pharma Group Ltd.
入组人数: 8
试验地点: 1
主要终点: Percentage of parent drug and its metabolites in plasma to total radioactivity exposure (% AUC) in human 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

This is a phase 1, single-center, single-dose, open-label mass-balance study to evaluate radioactive recovery rate, radioactive PK characteristics, metabolite identification, and to observe the safety in healthy male subjects of [14C] LPM3770164.

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 Chinese males;
•Age at informed consent: 18-45 years (including boundary value);
•Body mass index (BMI) range of 19-26 kg/m2 (including the boundary value), and body weight of not less than 50 kg;
•There is no plan to have children or donate sperm within 1 year after the participant signs the informed consent form and the participant voluntarily takes strict contraceptive measures within 1 year after signing the informed consent form and completing the trial;
•Fully understand the purpose and requirements of this study, and voluntarily sign the informed consent form;
•Able to communicate well with the investigators and be able to complete the trial according to the protocol.

排除标准

•Abnormal and clinically significant vital signs, physical examination, chest X-ray (anteroposterior), ophthalmic examination, anal digital examination and abdominal B ultrasound examination;
•Abnormal laboratory examination during the screening period, and clinically significant according to the investigator's judgment:
•QTcF interval > 450 ms in men; or other abnormalities are clinically significant in the judgment of the investigator;
•Abnormal tests of hepatitis B surface antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), treponema pallidum antibody and human immunodeficiency virus antibody are clinically significant at the investigator's discretion;
•Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicine, food supplements within 4 weeks prior to screening;
•Use of any drugs that inhibit or induce hepatic drug metabolizing enzyme activity within 4 weeks prior to screening;
•History of any clinically significant disease or disease or condition that may affect the results of the trial;
•History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, tachycardia, atrioventricular block, QT prolongation syndrome or a family history of QT prolongation syndrome symptoms;
•. Patients with dysphagia, esophageal stenosis or gastrointestinal diseases that cause clinically significant symptoms or with a history of severe vomiting and diarrhea in the week prior screening;
•Patients who previously underwent surgery that would affect the absorption, distribution, metabolism and excretion of drugs, or had undergone major surgery or had incomplete healing of surgical incision within 6 months prior to the screening period; or planned to undergo surgery during the study period;
•History of drug, food, or environmental allergy, especially to components similar to the investigational product, or a known allergic constitution;
•Patients with symptomatic hemorrhoids or diseases accompanied by regular/ongoing hematochezia, irritable bowel syndrome, and inflammatory bowel disease;
•History of congenital or acquired urinary tract stenosis, prostatic hyperplasia, or abnormal bladder function;
•Habitual diarrhea or average bowel movement frequency less than once daily;
•Alcoholics or regular drinkers within 6 months before screening, that is, drinking more than 14 units of alcohol per week, or alcohol breath test results > 0 mg/100ml at screening, or drinkers within 48 hours before the use of the test drug, or unable to abstain from alcohol during the test;
•The average daily smoking amount in the 3 months before screening is greater than 5 cigarettes or habitual use of nicotine-containing products, or unable to abstain during the trial;
•Previous history of drug abuse or drug abuse, or positive urine drug abuse screening;
•Excessive consumption of tea, coffee and/or caffeine-rich beverages, grapefruit juice and other beverages that affect liver enzyme activity per day within 3 months before screening, or inability to abstain during the trial;
•Those with special requirements for diet or failing to comply with the unified diet;
•Those who plan to have strenuous exercise during the trial;
•Workers engaged in long-term exposure to radioactive conditions, or those with significant radioactive exposure;
•Blood loss or blood donation;
•Those with a history of fainting, blood, or difficult to collect blood or unable to tolerate venipuncture blood collection;
•Those who have participated in any clinical trial within 3 months prior to screening and have received investigational drugs or used investigational devices; or those who plan to participate in other clinical trials during this study;
•Those who have received vaccination within 4 weeks prior to screening or plan to receive vaccination during the trial to 1 month after the end of the trial.

研究组 & 干预措施

[14C] LPM3770164

Experimental

20 mg/150 µCi [14C] LPM3770164

干预措施: [14C] LPM3770164 (Drug)

结局指标

主要结局

Percentage of parent drug and its metabolites in plasma to total radioactivity exposure (% AUC) in human plasma