Renal insufficiency
Conditions
Interventions
Moderate renal insufficiency group:Keprasan hydrochloride tablet was taken orally 20mg once on an empty stomach
Severe renal insufficiency group:Keprasan hydrochloride tablet was taken orally 20mg once on an empty stomach
Normal renal function group:Keprasan hydrochloride tablet was taken orally 20mg once on an empty stomach
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)18 to 75 years old (including the critical value), both men and women; 2) Female subjects weighing =45 kg, male subjects weighing =50 kg, body mass index (BMI) in the range of 18.0~32.0 kg/m2 (BMI = weight (kg)/height 2 (m2)), including boundary values; 3) Healthy subjects meet: eGFR=90 mL/min/1.73m2; Patients with moderate renal insufficiency: 30=eGFR=59 mL/min/1.73m2; Patients with severe renal insufficiency: eGFR < 30 mL/min/1.73m2 and no dialysis treatment (eGFR estimation of subjects was calculated using MDRD formula); 4) The renal function was stable, and within 30 days before administration, the results of two eGFR tests were consistent (one test result outside the hospital could be accepted), and both met the diagnostic criteria for moderate/severe renal insufficiency; 5) Each healthy subject should be matched according to the average age (±10 years) and average weight (±10kg) of all subjects with renal dysfunction (including moderate and severe); 6) The subject undertakes to have no family planning, no sperm donation plan, and to take appropriate contraceptive measuresto avoid pregnancy of the partner during the period of administration to 6 months after withdrawal of the drug; 7) Voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be enrolled in this study: 1) Have a history of allergy to caprazan or any investigational drug component, or a known allergen, or a history of specific allergic disease or drug allergy; 2) Participants who underwent heavy surgery within 3 months prior to screening, or those who underwent surgery that may significantly affect the in vivo process or safety evaluation of the study drug, were judged by the investigators to be unsuitable for participation; 3) Use of other clinical trial drugs within 3 months prior to screening or plan to participate in other clinical trials during the study period; 4) People who have lost or donated more than 200 mL of blood within 3 months prior to screening, or who intend to donate blood during the trial or within 1 month after the trial ends; 5) those who consumed an average of more than 14 units of alcohol per week in the 3 months prior to screening (1 unit =360 mL beer with 5% alcohol or 45 mL spirits with 40% alcohol or 150 mL wine with 12% alcohol) or were unable to abstain from alcohol during the trial period or who exhaled positively for alcohol; 6) Smokers who smoked an average of more than 10 cigarettes or equivalent tobacco per day in the 3 months prior to screening or who could not quit smoking during the trial period; 7) Those who received inactivated/attenuated vaccines within 1 month prior to screening or plan to receive inactivated/attenuated vaccines during the trial; 8) Concurrent use of any moderately active inducer or inhibitor of CYP3A enzyme within 1 month prior to screening; 9) had taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (averaging more than 8 cups per day, 200 mL per cup) in the 2 weeks prior to the first dose; 10) infectious disease test (human immunodeficiency virus antibody and antigen P24, hepatitis B virus surface antigen, hepatitis C virus IgG antibody, anti-treponema pallidum antibody) positive; 11) Those who have a history of drug abuse, drug use or test positive for drug abuse screening; 12) Pregnant or lactating women, or pregnancy test positive; 13) Can not tolerate venipunctures or have a history of fainting needles and fainting blood; 14) Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included. Healthy subjects who meet exclusion criteria 15-16 cannot be enrolled: 15) Laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function), physical examination, vital signs examination, 12-lead electrocardiogram examination, chest X-ray, abdominal B-ultrasound examination results, etc. are judged by clinicians to be abnormal and clinically significant; 16) Have used or are using any prescription drug, over-the-counter drug, any vitamin product or Chinese herbal medicine within 2 weeks before the first dose; Patients with renal insufficiency who met exclusion criteria 17-22 could not be enrolled: 17) Have had a kidney transplant and/or required kidney dialysis during the study; 18) Incontinence or no urine (such as < 100mL/d); 19) In addition to the condition itself causing renal insufficiency, the subject has a medical condition or medical history that may affect drug absorption, distribution, metabolism, or excretion (e.g. Inflammatory bowel disease, gastric u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK(Cmax AUC0-t AUC0-8); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK(Tmax T1/2 CL/F Vz/F,,and so on);Safety evaluation index; | — |
Countries
china
Contacts
Public ContactJe Pan /Huaying Shen
The Second Affiliated Hospital of Soochow University
Outcome results
None listed