Prostate Cancer
Conditions
Interventions
25mg group:4 volunteers were given 25 mg of the test drug
75mg group:Six volunteers were given 75 mg of test drug and two volunteers were given placebo
150mg group:Eight volunteers were given 150 mg of test drug and two volunteers were given placebo
300mg group:Eight volunteers were given 300 mg of test drug and two volunteers were given placebo
600mg group:Eight volunteers were given 600 mg of test drug and two volunteers were given placebo
900mg group:Eight volunteers were given 900 mg of test drug and two volunteers were given placebo
1200mg group:6 volunteers were given 1200 mg of test drug and two volunteers were given placebo
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age = 18 years and = 65 years, male; 2) Weight = 50.0 kg with a body mass index (BMI) between 19 ~ 26 kg/m2, including thresholds; 3) The subjects had no birth plan and voluntarily took medically approved contraceptive measures within 3 months after the screening visit, including but not limited to: correct use of male condoms, abstinence, and no sperm donation plan; Or the spouse uses hormonal contraceptives, intrauterine device or intrauterine hormone release system, or either party has undergone sterilization; 4) The subject voluntarily signs a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria will be excluded: 1) Those with abnormal vital signs or clinically significant abnormalities in physical examination, electrocardiogram, or laboratory tests (as judged by the clinical investigator as judged by the clinical investigator); 2) Persons who have suffered or are currently suffering from any clinically serious diseases of the circulatory, endocrine, nervous, digestive, respiratory, genitourinary, hematological, immune, psychiatric and metabolic abnormalities or any other diseases that may interfere with the test results; 3) Have cardiac disease, including but not limited to risk factors for congenital long QT syndrome, tip-twist heart disease or tip-twist heart disease (e.g., cardiac insufficiency, hypokalemia, family history of long QT syndrome), current use of Class IA [e.g., quinidine or procainamide or Class III [e.g., amiodarone or sotalol] antiarrhythmic drugs or other drugs known to have an effect on the QT interval QTc interval (QTcF) =450 ms, or PR interval >200 ms or QRS interval corrected by Fridericia's criteria at screening >200 ms or QRS interval =120 ms, or the difference between QTcF at D-1 and the screening period is >60 ms; 4) screening period ALT, AST, TB exceeds the upper limit of normal (ULN) 5) serum creatinine Cr exceeding ULN or creatinine clearance (CCr) <80 mL/min during the screening period; 6) those with testosterone (T) levels below the lower limit of normal at the time of screening 7) Those with a history of drug, food or other substance allergy 8) who have undergone surgical procedures within 4 weeks prior to screening, or who are scheduled to undergo surgical procedures during the study 9) who have taken any medication or health product (including herbal remedies) within 14 days prior to screening 10) Those who have used any drug that inhibits or induces hepatic metabolism of drugs within 30 days prior to screening (e.g., inducers - barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole, etc.; inhibitors-SSRI antidepressants, cimetidine, diltiazem, verapazem, etc, (diltiazem, verapamil, fluoroquinolones, etc.); 11) GnRH agonists or GnRH receptor antagonists within 6 months prior to screening, or the use of any androgenic or anti-androgenic drugs prior to screening. 12) Participating in any clinical trial and taking any clinical trial drug within 3 months prior to screening 13) blood donation or massive blood loss (= 200 mL), transfusion or use of blood products within 3 months prior to screening; 14) Those who have special dietary requirements and cannot comply with a uniform diet; 15) Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day; those who have ingested any food or beverage containing caffeine, xanthines, or that has the potential to affect the outcome of the test (e.g., tea, chocolate, coffee, cola, etc.) within 48 h prior to administration, or those who do not agree to discontinue consumption of the above foods or beverages during the study period; 16) who have consumed food or beverage containing enzymes that induce or inhibit liver metabolism (e.g. grapefruit, dragon fruit, mango) within 7 days prior to dosing,or who do not agree to stop consuming the above foods or beverages during the study; 17) smokers or smokers who smoked more than 5 cigarettes per day in the 3 months prior to screening or who were unable to stop using any tobacco pro
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Urine Routine;Convenient routine;Blood Transfusion IV; | — |
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Physical Examination;Blood Count;Blood Biochemistry;12-lead electrocardiogram;Adverse Events;Cmax;Tmax;AUC0-t;AUC0-8;t1/2;?z;Luteinizing hormone, LH;follicle stimulating hormone, FSH;testosterone; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed