NCT07644442已完成1 期
A Single-center, Open-label, Single-dose Phase I Clinical Study to Investigate the Human Mass Balance in Healthy Chinese Adult Male Subjects Following a Single Oral Dose of 300 mg/200 µCi [14C] HMPL-453
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Hutchmed
- 入组人数
- 6
- 试验地点
- 1
研究概览
简要总结
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HMPL-453
详细描述
- To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]HMPL-453 in healthy subjects, obtain the data on human radioactivity excretion rate and determine the main excretion pathways;
- To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of [14C]HMPL-453 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways;
- To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of [14C]HMPL-453, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the ratio of total radioactivity concentration in whole blood/plasma at different time points;
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •The subjects fully understand the content of the experiment, the process and possible adverse reactions, voluntarily sign the informed consent form, can communicate well with the researchers, and can complete all experimental procedures as specified in the protocol;
- •Healthy male subjects aged 18-45 years (inclusive, based on the time of signing the informed consent form);
- •Body weight ≥50 kg, body mass index (BMI) 19~26 kg/m2 (including limit values);
- •Subjects must commit to having no plans for pregnancy or sperm donation from the time of signing the informed consent form until 180 days after the end of the study medication administration. If the sexual partner is a female of childbearing potential, then a highly effective method of contraception should also be used.
排除标准
- •History of severe allergies (such as drug allergies) and acute allergic rhinitis or food allergies within 2 weeks prior to screening, allergic to any investigational drug (or its excipients) given in this study;
- •History of hypertension, or baseline blood pressure: systolic ≥140 mmHg and/or diastolic ≥90 mmHg;
- •Existing or occurring during the screening period clinically abnormal manifestations that need to be excluded (as judged by the researcher), including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal diseases affecting oral or absorption of drugs), blood and lymphatic system, urinary system, endocrine system, immune system;
- •History of gastrointestinal surgery, kidney surgery, cholecystectomy, etc., which the researchers judge may affect drug absorption or excretion;
- •Abnormal ophthalmological examination results have clinical significance, corrected visual acuity <1.0 or with the following history of eye diseases: non-arteritic anterior ischemic optic neuropathy (NAION), color vision abnormalities, hereditary retinal degeneration (such as pigmentary retinopathy), macular degeneration, retinal detachment, corneal lesions confirmed by ophthalmological examination, including but not limited to bullous keratopathy, band keratopathy, corneal abrasion, corneal ulcer, keratitis, etc.;
- •Anal diseases with periodic/ongoing bleeding;
- •History of vomiting and diarrhea within the past week;
- •Subjects who have used any prescription drugs within the past 30 days;
- •History of any non-prescription drugs and herbal supplements (including but not limited to vitamins, preventive treatments, Chinese herbal medicines, plant-based health products, etc.) taken within the past 14 days;
- •Screening period vital signs, physical examination, chest frontal and lateral films, and laboratory tests (including routine blood tests, blood biochemistry, routine urine tests, thyroid function, coagulation function, stool analysis, etc.) results are judged by the researcher to be clinically significant abnormalities (CS);
- •During the screening period, clinically significant abnormalities appear on the 12-lead ECG, or baseline QTcF interval >450 ms, or there is a history of QTc interval prolongation syndrome or sudden death in the family. If the ECG cannot display the QTcF result, please use the following formula to calculate: QTcF=QT/∛RR (RR=60/heart rate);
- •Creatinine clearance rate ≤90 mL/min estimated by the Cockcroft-Gault formula [(140-age) × weight (kg)] / [72 × serum creatinine (mg/dL)];
- •Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody, or syphilis spirochete antibody;
- •Irregular or difficult bowel movements, or other conditions that the researcher determines may affect stool sample collection;
- •Subjects who smoked more than 10 cigarettes per day in the past 3 months, and could not completely quit smoking during the study period;
- •Frequent drinkers in the past 6 months, i.e., those who drink more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL 40% alcohol spirits or 150 mL wine), or those who test positive for alcohol breath test during the screening period;
- •Drug abuse or dependence, or positive urine drug abuse screening;
- •Subjects consumed foods, juices or beverages containing alcohol, grapefruit, pomelo, citron, orange and caffeine within 72 hours prior to the first dose, and did not agree to abstain from them during the study period;
- •Subjects who have used blood products within the past 2 months; screen for those who have donated blood (including component donation) or lost ≥400 mL of blood within the past 3 months, screen for those who have donated blood (including component donation) or lost ≥200 mL of blood within the past 1 month, or plan to donate blood or blood components during the study period or within 1 month after the end of the study;
- •Poor venous blood collection assessment, fear of needles, fear of blood or difficulty in collecting venous blood;
- •Having participating in other drug clinical trials within the past three months;
- •Workers engaged in work that requires long-term exposure to radioactive conditions; or those who have had significant radiation exposure within 1 year prior to administration [≥2 chest/abdominal computed tomography (CT) scans, or ≥3 other types of X-ray examinations] or participated in radioactive drug labeling trials;
- •Subjects who have been vaccinated within 30 days before administration, and those who plan to be vaccinated within two weeks after administration;
- •According to the researchers' judgment, the subject has any other disease or condition that may affect the normal completion of the experiment or the evaluation of the research data, or any other situation that is not suitable for participating in this study. -
研究者
研究点 (1)
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