Hyperuricemia
Conditions
Interventions
Group A:SHR4640+repaglinide+midazolam
Group B:SHR4640+repaglinide+midazolam+placebo
Group C:placebo+repaglinide+midazolam
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in this trial: 1. Voluntarily sign the informed consent before the start of the activities related to this trial, and be able to understand the procedures and methods of this trial, and be willing to strictly comply with the clinical trial protocol to complete this trial; 2. Male or female who aged between 18 and 45 years old (including upper and lower limits based on the time of signing the informed consent); 3. Weight = 50 kg for male, weight = 45 kg for female, and body mass index (BMI): 19~26 kg/m2 (including upper and lower limits); 4. No birth plan and agree to use highly effective non-pharmacological contraception methods from the signing of the informed consent to at least 28 days after the last dose of the test drug (see Annex 1 for details), and no sperm or egg donation plan.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if they meet any of the following criteria: 1. Those who have a history of tobacco addiction (average of >5 cigarettes per day) in the 3 months prior to signing the informed consent form, or inability to stop using any tobacco-based products during the trial; 2. Average daily alcohol intake within 3 months prior to signing the informed consent form exceeding 7 g (approximately 200 ml of beer, 70 ml of wine, or 22 ml of low-potency liquor) for women and 14 g (approximately 400 ml of beer, 140 ml of wine, or 45 ml of low-potency liquor) for men; or those who are unable to abstain from alcohol during the trial; 3. Consumption of any beverage or food containing grapefruit within 7 days prior to randomization; or consumption of any beverage or food containing methylxanthines, such as coffee, tea, cola, and chocolate within 2 days prior to randomization; 4. Those who are allergy, or allergy or suspected allergy to SHR4640 tablets, repaglinide or midazolam; 5. Substance abusers, or those who are positive for urinary substance abuse screening at screening; 6. Those who have a history of any clinically serious disease or any disease or condition that, in the opinion of the investigator, may affect the outcome of the trial, including, but not limited to, a history of circulatory, endocrine, neurological, gastrointestinal, urological, or hematologic, immunologic, psychiatric, and metabolic disorders; 7. Those with contraindications to repaglinide (type 1 diabetes mellitus, patients with C-peptide negative diabetes mellitus, patients with diabetic ketoacidosis with or without coma); 8. Those with contraindications to midazolam (patients with acute angle-closure glaucoma, severe respiratory insufficiency, sleep apnea syndrome, myasthenia gravis, schizophrenia, severe depressive state); 9. Vital signs, physical examination, laboratory tests, cardiac ultrasound, abdominal ultrasound or chest imaging at screening suggesting the presence of abnormalities judged by the investigator to be clinically significant; 10. Urinary ultrasound at screening suggesting the presence of stones or crystals in the urinary system; 11. Previous history of acute kidney injury or acute kidney injury prior to randomization; 12. Serum uric acid is greater than 420 µmol/L at screening, or a history of hyperuricemia and/or gout; 13. 12-lead electrocardiogram with QTcF > 450 ms, PR interval > 200 ms, QRS wave cluster time limit > 120 ms, or HR > 100 bpm at screening, or the presence of other abnormalities judged by the investigator to be clinically significant; 14. Previous risk factors for tip-torsion ventricular tachycardia, such as heart failure, hypokalemia, or short QT syndrome, long QT syndrome, or a family history of first-degree relatives with unexplained sudden death in young adulthood (=40 years of age), drowning, or sudden infant death syndrome ; 15. Those who are positive for hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies, or syphilis antibody at screening; 16. Use of any prescription, over-the-counter, herbal, or dietary supplement within 2 weeks prior to randomization; 17. Systemic therapy with inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4), CYP2C8, or inducer analogs within 4 weeks prior to randomization (see Annex 2 for details); 18. Participants who have participated in a clinical trial of any other drug or medical device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK outcome;Safety outcome; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed