Depression
Conditions
Interventions
Experimental group1:DC561043 (4 mg, single dose)
Experimental group2:DC561043 (12 mg, single dose)
Experimental group3:DC561043 (30 mg, single dose)
Experimental group4:DC561043 (60 mg, single dose)
Experimental group5:DC561043 (80 mg, single dose)
Experimental group6:DC561043 (100 mg, single dose)
Experimental group7:DC561043 (30 mg, qd*14d)
Experimental group8:DC561043 (60 mg, qd*14d)
Experimental group9:DC561043 (80 mg, qd*14d)
Fasting–normal meal–high-fat and high-calorie meal group10:In period 1, a single oral dose of DC561043 tablets 30 mg will be administered under fasting conditions. In period 2, a single oral dose of
Normal meal–high-fat and high-calorie meal-fasting group11:In period 1, a single oral dose of DC561043 tablets 30 mg will be administered after a normal meal. In period 2, a single oral dose of DC561
High-fat and high-calorie meal-fasting–normal meal group12:In period 1, a single oral dose of DC561043 tablets 30 mg will be administered after high-fat and high-calorie meal. In period 2, a single o
Sponsors
Shanghai Xuihui Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Gender: Healthy male; 2. Age: 18 to 45 years old (inclusive); 3. Body weight: >=50 kg, with a body mass index [BMI = weight (kg) / height² (m²)] within the range of 19.0 to 26.0 kg/m^2 (inclusive of boundary values); 4. Results of vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, urinalysis), 12-lead electrocardiogram, and chest X-ray (posteroanterior view) are normal or judged by the investigator as abnormal without clinical significance; 5. Full understanding of the trial content, procedures, and potential adverse reactions, voluntary participation, and signing of the informed consent form; 6. Ability to communicate well with the research staff, and to understand and comply with the relevant requirements of this trial. Note: The inclusion criteria was used for three parts.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution, history of allergic diseases, or known allergy to the investigational product or its excipients, or related formulations; 2. History of severe diseases affecting the liver, kidneys, digestive system, endocrine system, cardiovascular and cerebrovascular systems, nervous system, metabolic system, hematopoietic system, respiratory system, or autoimmune system, or related medical history; 3. History of psychiatric disorders, drug abuse, or drug dependence; 4. History of any condition, surgery, or trauma within 3 months before the first dose that may affect the trial safety or drug pharmacokinetics, or plans to undergo surgery during the trial period; 5. Difficulty swallowing tablets, inability to adhere to a standardized diet, or intolerance to high-fat, high-calorie meals (applicable only to participants in the FE trial); 6. Difficulty with venous blood collection, intolerance to venipuncture/indwelling needle blood draw, or history of needle or blood phobia; 7. Excessive consumption of tea, coffee, or caffeinated beverages (more than 8 cups per day, 1 cup = 250 mL) within 3 months before screening; or intake of chocolate, any caffeinated, alcoholic, grapefruit, grapefruit juice, or xanthine-rich foods or beverages within 48 hours before the first dose; 8. Alcohol consumption exceeding 21 standard units per week within 3 months before screening (1 standard unit contains 14 g of alcohol, e.g., 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine); or a positive alcohol breath test result; 9. Smoking =10 cigarettes per day within 3 months before screening; 10. Use of any prescription drugs, over-the-counter medications, herbal medicines, or health supplements within 14 days before the first dose; 11. Participation in another drug clinical trial and receipt of investigational medication within 3 months before the first dose; 12. Donation or significant loss of blood (>400 mL) or receipt of blood transfusion within 3 months before the first dose; 13. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody; 14. Use of illicit drugs within 3 months before screening or positive urine drug abuse screening (morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine); 15. Abnormal and clinically significant chest X-ray (posteroanterior view) results; 16. Plans for pregnancy or sperm donation during the entire trial period and for 3 months after the last dose, or unwillingness to use effective contraception during the trial (e.g., complete abstinence, condoms, sterilization, partner’s use of intrauterine device/vaginal ring/spermicide-containing cervical cap or diaphragm, or post-trial hormonal contraception); 17. Staff involved in the research project, employees of the sponsor, or their immediate family members (including spouses, parents, children, and siblings, whether by blood or legal relationship); 18. Other factors deemed by the investigator as unsuitable for participation in the trial. Note: The exclusion criteria was used for three parts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory tests (Blood routine, blood chemistry, and urinalysis);Vital signs;12-lead electrocardiogram indicators;Physical examination;Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of DC561043;Peak concentration;Peak time;Half-life;Area under the concentration-time curve, 0-t ;Area under the concentration-time curve, 0-8;Clearance;Apparent volume of distribution;Mean Residence Time?;Elimination rate constant;Accumulation Ratio?;Degree of fluctuation; | — |
Countries
China
Contacts
Public ContactYanmei Liu
Shanghai Xuihui Central Hospital
Outcome results
None listed