Locally advanced or metastatic non-small cell lung cancer (NSCLC) [Only non-drug-resistant rare epidermal growth factor receptor (EGFR) mutations, including L861Q, G719X and/or S768I]
Conditions
Interventions
Experimental group:[14C]sutertinib maleate
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects aged 18-50 years (including the critical value); 2. Body weight >=50kg and body mass index (BMI) within the range of 19.0 to 28.0 (excluding the upper limit of 28); 3. No serious diseases, and no abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), positive chest radiograph and laboratory examination (including blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function, etc.) during the screening period, or abnormalities judged by clinicians have no clinical significance; 4. For fertile male subjects, abstain from sex or use effective contraception for 6 months from the start of the study to the last study administration; 5. Able to communicate with clinical staff, fully understand the purpose of the study and comply with the requirements of the study by signing the informed consent indicating willingness to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Any medical condition (such as cardiovascular, liver, kidney, digestive tract, immune blood, endocrine, metabolic, neurological, psychiatric, etc.) that the investigator has determined may affect drug absorption, distribution, metabolism, and excretion or may impair adherence to the study protocol, especially a history of dysphagia, digestive tract ulcers, or any gastrointestinal system disease that may affect drug absorption; 2. HIV antibody (HIV-AB), hepatitis C virus antibody (HCV-Ab), hepatitis B virus surface antigen (HBs-Ag), Treponema pallidum specific antibody (TP-Ab) any positive results; 3. Had major surgery (as determined by the investigator based on the patient's medical history) or major trauma within 6 months prior to taking the study drug, or planned to have surgery during the study period; 4. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; 5. Hemorrhoids or perianal disease with regular/bleeding in the stool, or screening/baseline fecal occult blood test positive; 6. Allergic constitution, if known to have a history of allergy to two or more substances; May be allergic to the active ingredient or excipients of the investigational drug as determined by the investigator; 7. Patients who have participated in clinical trials of any drug or medical device as a patient within 3 months prior to screening; 8. Binge drinking or average consumption of more than 14 units per week (1 alcohol unit =360 mL 5% alcohol beer or 45 mL 40% alcohol spirits or 150 mL wine with 12% alcohol) in the six months prior to screening, or positive breath test for alcohol; 9. Smokers who smoked more than 5 cigarettes per day (or used the equivalent amount of nicotine products) in the 3 months before the smoking or screening period, or were unable to quit during the trial; 10. Patients who have had blood loss or donated 400mL in the 3 months before the screening period, or who plan to donate blood within 1 month after the end of the test; 11. Excessive consumption (8 or more cups per day, 1 cup =250mL) of strong tea, coffee or caffeinated beverages in the 3 months prior to screening; Food or drink that produce caffeine or contain xanthine after metabolism (such as coffee, strong tea, chocolate, cola, etc.), strenuous exercise should not be prohibited within 48 hours before administration; Or fail to follow a uniform diet; 12. Urine test positive or history of drug abuse in the past five years or use of soft drugs (e.g., cannabis, ecstasy, KEN powder, hemp, etc.) in the three months prior to screening or hard drugs (e.g., cocaine, heroin, methamphetamine, etc.) in the year prior to screening; 13. Use of any medicines, including Chinese herbs, vaccines, vitamins, dietary supplements, etc., in the 1 month or 5 half-life period prior to screening, whichever is the older; 14. Foods containing CYP3A4 potent inhibitor or potent inducer used within 1 month before screening, such as grapefruit, dragon fruit, mango, grape or juice containing the above fruit components; 15. Any drug that inhibits or induces liver metabolism of drugs has been used in the 30 days prior to the screening period (e.g., inducers, including barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole;Inhibitors, including SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 16. Difficulty in venous blood collection, inability to tolerate venipuncti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of total radioactivity in whole blood and plasma;Cumulative excretion of drugs;Proportion of technical drugs and metabolites; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of unlabeled sutertinib and its main metabolite M6-3 in plasma; | — |
Countries
China
Contacts
Public ContactShao Feng
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed