Chinese adult healthy volunteers
Conditions
Interventions
[14C]ACC007:Single oral suspension containing 150mg/100µCi [14C] ACC007
Sponsors
The First Hospital Affiliated of Soochow University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Those who meet all the following conditions are eligible for the study: 1) Healthy adult males; 2) Aged 18~45 years of age (including boundary value); 3) Body weight: body mass index (BMI) between 19~26 kg/m2 (including boundary values); 4) Voluntary signing of informed consent; 5) Volunteers can communicate well with investigators and be able to perform tests in accordance with the requirements of the program.
Exclusion criteria
Exclusion criteria: Laboratory examination: 1) The investigators estimate the the abnormality of laboratory tests (blood routine, blood biochemistry, blood coagulation, urine routine, fecal routine + occult blood), thyroid function, 12 lead ECG, X-ray (positive position), abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney)is of clinical significance; 2) Any one of ALT, AST or creatinine is greater than the upper limit of normal; 3) Positive hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody; Medication history: 4) Take any drugs that inhibits or induces the metabolism of drugs(especially CYP2C19) in the liver within 30 days before the screening period (such as inducers - barbiturates,carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentin; inhibitors - omeprazole,ketoconazole, fluvoxamine, fluoxetine, venlafaxine, SSRI antidepressants, cimetidine, diltiazem, macrolides , verapamil, imidazole antifungal drugs); 5) Have used any prescription drugs and Chinese herbal medicines within 1 month before screening, and used over-the-counter drugs or food supplements, such as vitamins and calcium supplements, within 2 weeks; 6) Any clinical trial drug was used within 3 months before the trial administration, or the withdrawal time was shorter than 6 half lives of the trial drug at the time of enrollment (whichever is the longest); disease history and operation history: 7) Have a history of any clinically serious diseases or diseases or conditions that the researcher considers may affect the test results, including but not limited to circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases; 8) Patients with history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade ventricular tachycardia, ventricular tachycardia, QT prolongation syndrome, or QT prolongation syndrome symptoms and family history (proved by heredity or sudden cardiac death of close relatives in young age); 9) Major operations include, but are not limited to, anyone who has a significant risk of bleeding, prolonged general anesthesia, or incisional biopsy or obvious traumatic injury; 10) Allergic constitution, such as those who have been known to be allergic to two or more substances, or may be allergic to the test drug or its excipients as judged by the researcher; 11) Hemorrhoids or perianal diseases with regular / ongoing bleeding, irritable bowel syndrome, inflammatory bowel disease; Lifestyle: 12) Habitual constipation or diarrhea; 13) Drinking regularly during the first 6 months of alcoholism or screening, i.e., drinking more than 14 units of alcohol per week (1 units =360 ml beer or 45 ml alcohol, 40% spirits or 150 ml wines);or alcohol breath test results >= 20mg / dl during screening period; 14) Smoking or more than 1 cigarettes per day for 3 months before or during the screening period, and can not be abstinent during the test period; 15) Drug abuse or take soft drugs (e.g. cannabis) within 3 months before screening period, or take hard drugs (such as cocaine, amphetamines, piperidine, etc.) within 1 years before the screening period; 16) Habitual consumption of grapefruit juice or excessive tea, coffee, and / or caffeinated beverages and can not abstinent during the test period; Other: 17) Engage in workers who are exposed to rad
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radioactivity;Blood concentration; | — |
Countries
China
Contacts
Public ContactLiyan Miao
Outcome results
None listed