Metastatic breast cancer in postmenopausal women with estrogen receptor-positive or unknown status
Conditions
Interventions
Fed group:Healthy volunteers were randomized into two 15-participant crossover sequences. A washout period of =28 days separated the two treatment cycles. In Cycle 1, subjects received either 60 mg te
Fasting group:Healthy volunteers were randomized into two 15-participant crossover sequences. A washout period of =28 days separated the two treatment cycles. In Cycle 1, subjects received either 60
Sponsors
Bishan Hospital of Chongqing medical university,Bishan Hospital of Chongqing
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–65 years old (inclusive); Gender: males and postmenopausal females (including natural menopause or artificial menopause for more than 1 year); 2. Male participants must weigh at least 50.0 kg, and female participants at least 45.0 kg. Body Mass Index (BMI) = weight (kg) / height^2 (m^2), with a BMI range of 19.0–26.0 (inclusive); 3. Vital signs: pulse, blood pressure, and temperature are normal or any abnormalities are clinically insignificant; 4. Health status: based on medical history, there are no cardiovascular, liver, kidney, respiratory, digestive, neurological, blood, immune, tumor, mental, or endocrine/metabolic system diseases, and physical exams, 12-lead ECG, and lab tests are normal or any abnormalities are clinically insignificant, as judged qualified by the study doctor; 5. Male participants voluntarily agree not to plan a pregnancy or donate sperm for the next 6 months and agree to use effective contraception; 6. Able to read and understand the study-related written informed consent, sign the consent before the trial, and fully understand the study content, procedures, and possible adverse reactions; 7. Able to communicate well with the researchers and follow the study rules, including overnight stays, blood sample collection, etc., as defined in the protocol; 8. Apart from the blood samples collected in this study, participants agree not to donate whole blood or blood components (such as plasma or platelets) from the time they sign the informed consent until 30 days after completing the last study procedure.
Exclusion criteria
Exclusion criteria: 1. Laboratory tests show clinically significant abnormalities or there is a clinically significant diagnosis of the following diseases (including but not limited to gastrointestinal, kidney, liver, neurological, blood, endocrine, tumor, lung, immune, psychiatric, or cardiovascular diseases); 2. Recent (within 3 years) history of autonomic dysfunction and/or current medical history (such as, but not limited to, recurrent fainting, palpitations, angina, etc.); 3. History of endometrial hyperplasia or liver failure; 4. Clinically significant ECG abnormalities; 5. Known severe allergies (such as allergies to more than three allergens, lower respiratory tract-related allergies - allergic asthma, or allergies requiring glucocorticoid treatment); 6. Known allergy to the active ingredient "toremifene citrate" or any of its components (lactose, microcrystalline cellulose, corn starch, sodium carboxymethyl starch, etc.). 7. Anyone who has used any drugs that affect CYP3A4 enzyme activity within 28 days before the first dose of the study drug (such as: inducers—barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors—SSRIs, cimetidine, diltiazem, macrolides, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, azole antifungals); 8. Anyone who smoked more than 5 cigarettes per day in the 3 months before screening, smoked within 48 hours before taking the study drug, or cannot stop using any tobacco products during the trial; 9. Anyone who drank more than 14 units of alcohol per week in the 3 months before screening (1 unit ˜ 360 mL beer, 45 mL spirits, or 150 mL wine), drank within 48 hours before taking the study drug, or cannot abstain from alcohol during the trial; 10. Anyone who drank excessive tea, coffee, and/or caffeinated drinks daily (more than 8 cups, 1 cup ˜ 250 mL) in the 3 months before screening; 11. Anyone who donated =200 mL of blood in the 3 months before screening, had any component blood donations, lost a total of =200 mL of blood for any reason, or has a history of transfusion or blood product use; 12. Anyone who currently or in the last 6 months had indigestion, acid reflux, stomach bleeding, or peptic ulcer disease, frequently experienced heartburn more than once a week, or had any surgery that could affect drug absorption (such as cholecystectomy); 13. Anyone who took any prescription drugs, over-the-counter drugs, vitamins, herbal products, supplements, or hormones within 2 weeks before taking the study drug; 14. Anyone who consumed special diets (including dragon fruit, mango, grapefruit, or their beverages/foods) and/or purine-rich diets (anchovies, sardines, beef liver, beef kidney, etc.) within 48 hours before taking the study drug, or anything else that may affect drug absorption, distribution, metabolism, or excretion; 15. Anyone who tested positive for any of these: HIV antigen/antibody, hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), or syphilis antibody (TP); 16. Anyone with a history of drug abuse, drug use, or who tested positive for alcohol or drug screening. 17. Participated in a drug clinical trial within the three months prior to screening (counted from the last dose); 18. Had significant changes in diet or exercise habits within three months before screening, or did intense exercise within 48 hours before dosing; 19. Have special dietary requirements and cannot follow the standard diet (such as intolerance to standard meals or lactose intolerance) or h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-t;Tmax; | — |
Countries
China
Contacts
Public ContactChengyong Tang
Bishan Hospital of Chongqing Medical University
Outcome results
None listed