To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment

Last updated: March 16, 2025
Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Warts

Kidney Disease

Rosacea

Treatment

Hemay005

Clinical Study ID

NCT06380153
HM005PS1S07
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Fully understand the content, process and possible adverse reactions of the trialbefore the trial, and be able to complete the study and sign the informed consentaccording to the requirements of the trial protocol;

2.adults of both sexes aged 18-70 years old (both ends, whichever is based onwritten informed consent);

  1. The body weight of male subjects was not less than 50 kg and that of femalesubjects was not less than 45 kg. Body mass index (BMI) : 19-32 kg/m2 (including cut-off value);

4.The creatinine clearance rate (CLcr, calculated by Cockcroft-Gault formula) of thesubjects met the CKD staging criteria of the corresponding groups, namely mild renalimpairment: 60≤CLcr<90 mL/min; Moderate renal impairment: 30≤CLcr<60mL/min. At thesame time, according to the investigator's judgment, the creatinine clearance rateof the subjects was not expected to change significantly by the end of the study.

  1. Stable renal function: the interval between two creatinine tests was at least 3days (30 days before the first test result was acceptable), and the fluctuationvalue of serum creatinine results between the two tests (calculated by theformula: (the second result-the first result)/the first result) was less than 30%;

6.no new concomitant medications in the 2 weeks before screening, no adjustment inthe treatment regimen (including the type, dose, or frequency of medications) forunderlying diseases in the 4 weeks before screening, and no change in the treatmentregimen (except for drugs used temporarily on demand) during the study (except asspecified in the protocol), or no medication was used;

7.In addition to renal impairment and complications, the investigators were in goodphysical condition according to medical history inquiry, vital signs, physicalexamination, laboratory tests (blood routine, urine routine, stool routine, bloodbiochemistry, coagulation function, blood pregnancy (only female), 12-leadelectrocardiogram, chest X-ray, abdominal color Doppler ultrasound, etc.), and noother clinically significant abnormalities.

Exclusion

Exclusion Criteria:

  • 1.(Inquired) The subject has any of the following conditions: acute kidney failure,a history of kidney transplantation, or a need for kidney transplantation or anytype of dialysis during the planned trial period; Patients with urinary incontinenceor anuria; Patients with obstructive urinary tract diseases (such as urinary tractobstruction caused by urinary calculi, urinary tract obstruction caused by abdominalspace occupying lesions, etc.), and the investigator thought that they were notsuitable;
  1. (Inquiry) In addition to the disease causing renal impairment, patients withserious acute or chronic diseases of other vital organs within 1 year prior toscreening, including but not limited to diseases of the nervous system,cardiovascular system, blood and lymphatic system, immune system, liver,gastrointestinal system, respiratory system, metabolic system, skeletal systemand other systems, who were judged by the investigator to be not suitable forthe trial;

  2. (Inquiry) Any of the following occurred in the 6 months prior to study entry:Myocardial infarction, Congenital long QT syndrome, Torsades de pointes (including sustained ventricular tachycardia and ventricular fibrillation),right bundle branch block and left anterior hemiblock (bifascicular block),Unstable angina pectoris, coronary artery/peripheral artery bypass grafting,New York Heart Association (NYHA) class III or IV congestive heart failure,cerebrovascular accident, transient ischemic attack, or pulmonary embolism;

  3. (inquiring) patients with a history of depression or suicidal tendencies;

  4. (inquiry) patients who had severe gastrointestinal diseases or had digestivesystem surgery within 3 months before screening, which affected drug absorptionaccording to the investigator;

6.(inquiry) blood loss or donation of more than 400mL within one month beforescreening, or red blood cell transfusion;

  1. Screening laboratory test results met any of the following: (a) alanineaminotransferase (ALT) >2 times the normal value; (b) total bilirubin >1.5times the normal value; (c) neutrophil count <1.3×109/L; (d) hemoglobin <80g/L; (e) platelet count <80×109/L;

8.(inquiry) with specific allergic history (asthma, urticaria, eczema, etc.), orallergic condition (such as allergic to two or more drugs, foods or pollens), orknown allergic to PDE4 inhibitors (such as apast, roflumilast, etc.);

  1. (queried) drug users in the past 3 years or drug abuse in the past 5 years;

  2. screening positive for drug abuse (excluding those screened positive for drugabuse due to concomitant medications);

  3. with positive breath alcohol test (alcohol concentration >0mg/L);

  4. (inquired) drank more than 14 units of alcohol per week in the 3 months beforescreening (1 unit = 17.7 mL ethanol, i.e. 1 unit = 354 mL of 5% beer or 44 mLof 40% liquor or 147 mL of 12% wine), or could not abstain from alcohol duringthe study;

13.(inquired) smoked more than 5 cigarettes per day in the 3 months beforescreening, or could not stop using any tobacco products during the study;

  1. (questionnaire) consuming excessive amounts of tea, coffee and/or caffeine-richbeverages (> 8 cups, 1 cup =250 mL) per day in the previous 3 months;

  2. Hepatitis B, hepatitis C, HIV and syphilis tests have one or more clinicalsignificance;

  3. (inquiry) who had participated in and used other drug/device clinical trialswithin 3 months before screening;

  4. (inquiry) use of any drugs (e.g., inductors-barbiturates, pioglitazone,carbamazepine, phenytoin, glucocorticoids) that induce or inhibit hepaticdrug-metabolizing enzymes within 30 days before screening; Inhibitors: SSRIantidepressants, cimetidine, diltiazem macrolides, nitroimidazole, sedativehypnotics, verapamil, fluoroquinolones, antihistamines, isoniazid);

  5. (inquiry) who had used prescription drugs, over-the-counter drugs, healthsupplements, herbal products or vaccines other than those used to treat renalimpairment and other concomitant diseases within 2 weeks before screening;

  6. (inquiry) consumed any caffeine/xanthine/food or drink (such as strong tea,coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.)rich in caffeine/xanthine/which may affect the absorption, distribution,metabolism, and excretion of the drug in the investigator's decision fromscreening to -1 day of admission, or could not stop consuming the above food ordrink during the study;

  7. (inquiry) pregnant or lactating women, or subjects (including male subjects)who have plans to have children or to donate sperm or eggs from two weeksbefore the study to six months after the last dose of the study, and who areunwilling or unable to use effective contraception;

21.(inquiry) unable to eat or have swallowing difficulties, have special dietaryrequirements and/or cannot follow a uniform diet;

  1. (inquiry) with a history of epileptic seizures;

  2. (inquiry) can not tolerate venipuncture and/or have a history of dizziness;

24.subjects with other factors considered by the investigator to be ineligible forthe trial.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Hemay005
Phase: 1
Study Start date:
May 07, 2024
Estimated Completion Date:
December 31, 2025

Study Description

To evaluate the pharmacokinetics and safety of Hemay 005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment.

Connect with a study center

  • Union Hospital of Tongji Medical College; Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

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