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Completed
NCT07644442
Study on [14C]HMPL-453(FGFR Inhibitor) in Healthy Chinese Adult Male Subjects
Conditions: Mass Balance Study
Sex: Male
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 6
Sponsor: Hutchmed
Location: The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) Jinan Shandong
Summary
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of \[14C\]HMPL-453
Eligibility Criteria
Inclusion Criteria:
1. 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;
2. Healthy male subjects aged 18-45 years (inclusive, based on the time of signing the informed consent form);
3. Body weight ≥50 kg, body mass index (BMI) 19\~26 kg/m2 (including limit values);
4. 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.
Exclusion Criteria:
1. 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;
2. History of hypertension, or baseline blood pressure: systolic ≥140 mmHg and/or diastolic ≥90 mmHg;
3. 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;
4. History of gastrointestinal surgery, kidney surgery, cholecystectomy, etc., which the researchers judge may affect drug absorption or excretion;
5. Abnormal ophthalmological examination results have clinical significance, corrected visual acuity \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);
12. Creatinine clearance rate ≤90 mL/min estimated by the Cockcroft-Gault formula \[(140-age) × weight (kg)\] / \[72 × serum creatinine (mg/dL)\];
13. Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody, or syphilis spirochete antibody;
14. Irregular or difficult bowel movements, or other conditions that the researcher determines may affect stool sample collection;
15. Subjects who smoked more than 10 cigarettes per day in the past 3 months, and could not completely quit smoking during the study period;
16. 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;
17. Drug abuse or dependence, or positive urine drug abuse screening;
18. 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;
19. 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;
20. Poor venous blood collection assessment, fear of needles, fear of blood or difficulty in collecting venous blood;
21. Having participating in other drug clinical trials within the past three months;
22. 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;
23. Subjects who have been vaccinated within 30 days before administration, and those who plan to be vaccinated within two weeks after administration;
24. 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. -
Source: ClinicalTrials.gov (NCT07644442). StuddyBuddy aggregates publicly available trial information.