metastatic colorectal cancer (mCRC), gastrointestinal stromal tumor (GIST), hepatocellular carcinoma (HCC)
Conditions
Interventions
Sponsors
Beijing shijitan hospital affiliated to capital medical university
Eligibility
Sex/Gender
Male
Age
30 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male volunteers; 2. When signing the informed consent form, he is over 30 years old (including the boundary value) and has children who have no plans to give birth again and donate sperm; 3. Weight >=50.0 kg, and body mass index (BMI) is in the range of 19.0 ~ 28.0 (inclusive); 4. Past medical history, vital signs, physical examination, laboratory examination, electrocardiogram and chest imaging examination are normal or abnormal and have no clinical significance; 5. The subjects fully understand the content, process and possible adverse reactions of the test and voluntarily sign the informed consent form; 6. Subjects and their partners can take effective contraceptive measures during the trial and within one year after the trial.
Exclusion criteria
Exclusion criteria: 1 Those who entered other clinical trials and took corresponding experimental drugs within 3 months before screening, or who are participating in other clinical trials; 2 Patients who have undergone surgery within 3 months before screening; 3 Those who donated blood or lost blood >=400ml within 3 months before screening, or planned to donate blood or blood components within 3 months during or after the study; 4 Smoking habits (more than 5 cigarettes per day on average) within 3 months before screening or people who can't stop using any tobacco products during the trial; 5 Those who have been addicted to alcohol within 3 months before screening (drinking more than 14 units of alcohol per week: 1 unit = 285ml of beer, 25ml of spirits or 100ml of wine), or those who have positive breath test of alcohol, or those who can't accept alcohol prohibition during the whole test period after being selected; 6 Have used any drugs that inhibit or induce the metabolism of drugs in the liver within 30 days before screening (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole; Inhibitors-—SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 7 Those who took any prescription drugs orally within 2 weeks before screening; 8 Taking any over-the-counter drugs, vitamin products or Chinese herbal medicines orally within one week before screening; 9 Drug abuse screening is positive, or there is a history of drug abuse (such as methamphetamine, ketamine, benzodiazepine, cocaine, marijuana, morphine, etc.) within one year before screening; 10 Have any previous history of liver disease, and/or alanine aminotransferase and aspartate aminotransferase are higher than the upper limit of normal value; 11 Suffering from dysphagia or any history of gastrointestinal diseases that affect drug absorption (such as gastrectomy, atrophic gastritis, gastrointestinal bleeding and obstruction) or any history of clinically serious diseases such as respiratory system, circulatory system, urinary system, blood system, endocrine system, nervous system or mental disorder, or any disease or physiological situation that can interfere with the test results; 12 Those who are allergic to rigofibril or any ingredient in the research drug auxiliary materials, or allergic to any food or drug; 13 Those who can't follow the unified diet, or eat fruits that affect drug metabolism within 48 hours before administration, such as pitaya, mango, grapefruit, and/or any food or beverage containing xanthine such as chocolate, coffee and tea; 14 Hepatitis B surface antigen, treponema pallidum antibody, human immunodeficiency virus antibody or hepatitis C virus antibody are positive; 15 The researcher judges that there are other situations in which the subject is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration (Cmax) of regorafenib;Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0–t) of regorafenib;Area under the concentration-time curve from time 0 to 8 (AUC0–8) of regorafenib;Apparent distribution volume (Vz/F) of regorafenib and M-2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Observed time to Cmax (Tmax) of regorafenib and M-2;Half-life time (T1/2) of regorafenib and M-2;Clearance rate constant (?z) of regorafenib and M-2;Apparent clearance rate (CL/F) of regorafenib and M-2;Percentage of residual area (AUC_%Extrap) of regorafenib and M-2;Peak concentration (Cmax) of M-2;Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0–t) of M-2;Area under the concentration-time curve from time 0 to 8 (AUC0–8) of M-2; | — |
Countries
China
Contacts
Public ContactWang Xinghe
Beijing shijitan hospital affiliated to capital medical university
Outcome results
None listed