None listed
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy adult male; 2. Age: 18-45 years old (including boundary value); 3. Body weight: Body mass index (BMI) between 19.0-26.0 kg/m2 (including the boundary value), and the subject's weight is not less than 50.0 kg; 4. Voluntarily sign the informed consent; 5. The subject can communicate well with the investigator and complete the experiment in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. After a comprehensive physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, fecal occult blood), thyroid function, chest CT, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney) and other examinations are abnormal and clinically significant; 2. 12-lead electrocardiogram examination shows corrected QT interval >= 450 msec (using QTcF formula); 3. Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody positive; 4. New coronavirus infection screening: C-reactive protein is abnormal and has clinical significance, or the new coronavirus nucleic acid is positive; 5. Abnormal ophthalmic examination (slit lamp, intraocular pressure and fundus photography) with clinical significance; 6. Any drug that inhibits or induces liver drug metabolizing enzymes has been used within 30 days before the screening period; 7. Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements, such as vitamins and calcium supplements, within 14 days before the screening period; 8. Have any history of clinically serious diseases or diseases or conditions that the researchers believe may affect the results of the test, including but not limited to the circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immunity, spirit and metabolism medical history; 9. Any conditions that may affect drug absorption, such as gastrectomy, cholecystectomy, gastric bypass surgery, duodenectomy, colectomy, history of inflammatory bowel disease; 10. Previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, QT prolongation syndrome or QT prolongation syndrome symptoms and family history (evidenced by genetic evidence or close relatives who died suddenly from cardiac causes at a young age); 11. Have undergone major surgery or surgical incision not fully healed within 6 months before the screening period; major surgery includes, but is not limited to, any operation with significant bleeding risk, prolonged general anesthesia period, or incisional biopsy or obvious traumatic injury ; 12. Allergic constitution, such as those who are known to be allergic to two or more substances; or who are judged by the investigator to be allergic to the test drug or its excipients (such as lactose T80, silicon dioxide, sodium stearyl fumarate, etc.) ; 13. Hemorrhoids or perianal diseases with regular/current blood in the stool, irritable bowel syndrome, inflammatory bowel disease; 14. Habitual constipation or diarrhea; 15. Alcoholism or regular drinking within 6 months before the screening period, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine); or alcohol breath during the screening period Test result >= 20 mg/dL; 16. Those who smoke more than 5 cigarettes a day in the first 3 months of the screening period, or habitually use nicotine-containing products, and cannot quit during the test period; 17. Abusing drugs or using soft drugs (such as marijuana) 3 months before the screening period or taking hard drugs (such as: cocaine, amphetamines, phencyclidine, etc.) 1 year before the screening period; or urine drugs during the screening period test pos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative excretion rate of total radioactive material in excreta (urine and faeces);Whole blood/plasma total radioactivity ratio, PK parameter of plasma total radioactivity;PK parameters of FCN-437C and its major metabolites (if applicable) in plasma;Identify more than 80% of radioactive substances in excrement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, laboratory tests, vital signs, 12-lead electrocardiogram, physical examination; | — |
Countries
China
Contacts
Public ContactMiao Liyan
Medical Ethics Committee of the First Affiliated Hospital of Soochow University
Outcome results
None listed