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

Обзор

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.

Вмешательства

• Препарат [14C] LPM3770164
  The subjects are required to take 20 mg/150 µCi \[14C\] LPM3770164 tablet (s) in the fasted state with a total of approximately 240 mL of water to ensure completion within 5 minutes

Первичные конечные точки

• Recovery of total radioactivity in excreta (urine and feces) per collection period; [Срок оценки: within up to 40 days after dosing]
• Cumulative recovery of total radioactivity in excreta (urine and feces) [Срок оценки: within up to 40 days after dosing]
• Percentage of parent drug and its metabolites in plasma to total radioactivity exposure (% AUC) in human plasma [Срок оценки: within up to 40 days after dosing]
• Percentage of parent drug and its metabolites in urine and feces to administered dose (% administered dose) [Срок оценки: within up to 40 days after dosing]
• Identification of major metabolites in human plasma, urine and feces [Срок оценки: within up to 40 days after dosing]
• Peak concentration (Cmax) of total radioactivity in human plasma [Срок оценки: within up to 40 days after dosing]
• Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf) of total radioactivity in human plasma. [Срок оценки: within up to 40 days after dosing]

Вторичные конечные точки (1)

• Treatment-emergent adverse event [Срок оценки: From baseline to 40 days after doing]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Affiliated Hospital of Jiangnan University — Wuxi

Идентификаторы

NCT: NCT07516899 · LY03015/CT-CHN-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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