Hypertrophic cardiomyopathy
Conditions
Interventions
Healthy SUBJECTS group:HRS-1893 tablets
Mild renal insufficiency group:HRS-1893 tablets
Moderate renal insufficiency group:HRS-1893 tablets
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients should voluntarily sign informed consent before the trial and fully understand the content, process, and possible adverse reactions of the trial Understand and be willing to strictly abide by the clinical trial protocol to complete the trial; 2. Both men and women aged from 18 to 65 years old (inclusive of the cutoff value) on the date of signing the informed consent form; 3. Body mass index (BMI) 19.0-28.0 kg/m^2 (including boundary value), male body weight >= 50.0kg and = 45.0kg and 3 months) and stable (= 90mL/min, and =55%); 9. In this study, subjects with mild and moderate renal insufficiency were enrolled first, and then healthy subjects were enrolled as controls. Weight, age, and sex matched to subjects with renal insufficiency: a) The body weight of the healthy subjects was within the range of +/-10 kg of the mean body weight of the renal insufficiency subjects group; b) The age of the healthy subjects was within the range of the mean age of the renal insufficiency subjects group ±10 years; c) The number of subjects of each sex in the healthy subject group was similar to that in the renal insufficiency subject group (+/-1 case Subject/gender). 10. Female subjects of childbearing potential were required to use contraception for at least 30 days prior to screening and must have used it for the first time A serum pregnancy test was performed within the first 7 days and was negative; They must also be non-lactating. Be fertile Female subjects and male subjects whose partner is a woman of reproductive age must agree to begin by signing an informed consent form Avoid sperm/egg donation until
Exclusion criteria
Exclusion criteria: 1.Suspected allergy to the study drug or any component of the study drug; 2. Suffering from cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, Torsade de pointes (Tdp) or ventricular tachycardia, history of clinically significant T wave changes, myocardial infarction, angina pectoris; 3. Associated diseases with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular nutrition) Poor); 4. Family history of cardiomyopathy and/or unexplained heart failure; 5. Previous history of syncope; 6. Previous gastric or intestinal surgery that may affect drug absorption; 7. Pregnant and lactating women at screening and baseline visit; 8. Persons who plan to receive vaccination within 1 month before screening or during the course of the trial or within 1 month after dose; 9. Positive urine drug abuse screening at baseline visit; 10. Having a history of drug or drug abuse; 11. Participants who participated in a clinical trial of any drug or device within 3 months before screening (participation in a clinical trial was defined as receipt of the investigational drug or device); 12. Infectious diseases during the screening period were screened for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and human immunodeficiency virus antibody (or HIV antibody or P24 antigen) test any one positive; 13. Subjects who smoked more than 5 cigarettes per day during the 4 weeks before screening; 2.Subjects who consumed more than 15g of alcohol (15g of alcohol equivalent to 450mL beer or 150mL wine or 50mL light liquor per day in a week, or who could not abstain from smoking, alcohol and caffeinated food or beverage during the screening period and the experiment period, or who had special requirements for diet and could not follow the same diet; 14. The subject refused to discontinue any beverage containing methylxanthine for 48 hours before taking the study drug until the end of the study. Such as caffeine (coffee, tea, cola, chocolate, etc.) or alcoholic beverages or any fruit juice, strenuous exercise, or other factors affecting the absorption, distribution, metabolism, excretion, etc. 15. Patients with renal insufficiency: those who had taken any prescription drugs, over-the-counter drugs, Chinese patent medicine or food supplements other than those for renal insufficiency and other concomitant diseases within 2 weeks before taking the study drug; 3.Healthy subjects: taking any prescription drug, over-the-counter drug, herbal medicine within 2 weeks before taking the study drug, or taking medication 5 at the time of screening Within one half life; 4.Plan to take a non-trial drug during the trial; 16. Research Centre staff or others directly involved in programme implementation; 17. Other conditions considered by the investigator to be unsuitable for the trial, such as those that may increase the risk of the trial and affect the trial Compliance with the protocol or physical or psychological diseases or conditions that affect the completion of the trial; In addition to the exclusion criteria mentioned above, subjects with renal insufficiency who meet any of the following criteria will not be eligible for this study: 18. Participants with renal insufficiency who have undergone kidney transplantation, urinary incontinence, or anuria are deemed unsuitable for the study by the researchers; Within 2 weeks before administration, if the researcher determine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;CL/F;V/F; | — |
Countries
China
Contacts
Public ContactYang Mengchang
Sichuan Provincial People's Hospital
Outcome results
None listed