The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human

Exclusion Criteria

• •1. History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
• •2. Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody;
• •3. History of clinically significant disease or infection within 1 month before entering the study;
• •4. Abnormality in blood pressure, including hypertensive BP (SBP\>=140 mmHg, or DBP \>=90 mmHg), or hypotensive BP(SBP\<90 mmHg, or DBP \<=55 mmHg), Pulse rate\<55 bpm or \>100 bpm;
• •5. Long-QT syndrome or family history of it, or QTcB interval \> 450 ms; intraventricular blocks or left/right bundle branch block or QRS\>120ms; frequent ventricular ectopic beats (any 10s ECG ventricular premature beat \>= 1 in screening period); or abnormal resting heart rate (\> 100 bpm)
• •6. The following abnormal clinical laboratory values
• •1. HGB \< LLN, and is judged as clinically significant by the investigator；
• •2. Abnormal ALP, ALB,TP,CRE,ALT,AST,BIL,BUN, GLU value, and is judged as clinically significant by the investigator;
• •7. Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug or herbal drug, except for vitamins and paracetamol;
• •8. History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs;
• •9. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease;
• •10. Hemorrhoids or perianal disease with regular/perianal bleeding;
• •11. Allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the drug (microcrystalline cellulose, stearic acid, hydroxypropyl methylcellulose);
• •12. Have donated 500ml or more of blood or plasma 2 months prior to the study drug administration, or more than 50ml within 2 weeks prior to administration;
• •13. Vaccination was administered within 6 months prior to screening or during screening;
• •14. History of drug or alcohol abuse;
• •15. Smoking (\> 10 cigarette / day), drinking (\> 15 g, pure alcohol / day, equivalent to 450 ml beer, 150 ml wine or 50 ml low-alcohol liquor), or abusing drugs(MOP, METmAMP, MTD, THC, AMP positive) within last 3 months;
• •16. Subject with mentally ill and could not understand the property, scope and possible consequences of the study;
• •17. subject in prison or whose freedom is restricted by administrative or legal issues;
• •18. Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study;
• •19. Investigator, pharmacist, CRC or research associate;
• •20. Investigators think that subjects are not suitable to participate in the study;
• •21. Subjects who have participated in radiolabeled clinical study prior to drug administration;
• •22. Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations).