Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal Function

Last updated: October 26, 2023
Sponsor: Fujian Akeylink Biotechnology Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Corona Virus

Pneumonia

Covid-19

Treatment

GST-HG171 Tablets

Clinical Study ID

NCT06106126
GST-HG171-I-03
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This si a single-center, non-randomized, open, parallel, single-dose trial was designed to evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with impaired renal function.

Eligibility Criteria

Inclusion

Inclusion Criteria: All subjects are required to meet all of the following conditions

  1. Voluntarily sign informed consent prior to the start of activities related to thisstudy, be able to understand the procedures and methods of this study, and be willingto strictly follow the clinical trial protocol to complete this study;
  2. Subjects (including their partners) are willing to have no family planning andvoluntarily take highly effective contraception within 6 months after the last studydrug administration;
  3. Age range from 18 to 70 (including both ends) on the date of signing the informedconsent, both male and female;
  4. Male subjects weigh at least 50 kg and female subjects weigh at least 45 kg; Body massindex (BMI) 18-32 kg/m2 (including both ends); Subjects with normal renal function should also meet all of the following conditions:
  5. Physical examination, vital signs and electrocardiogram are normal or abnormal withoutclinical significance;
  6. The glomerular filtration rate should meet the following criteria: Subjects withnormal renal function: GFR≥90 mL/min;
  7. The following demographic matching criteria must be met during screening:
  8. The body weight was matched with that of the renal impairment group, with anaverage of ±10 kg;
  9. Age matching was performed with the renal impairment group, with the mean ±10years old;
  10. Gender matching was performed with the group of renal impairment, with the mean ±1 case; Subjects with renal impairment should also meet all of the following conditions:
  11. Have chronic kidney disease (CKD), have any indicators of kidney injury or have a GFRless than 60 mL/min for more than 3 months (outpatient medical records, inpatientrecords or laboratory records can be used as evidence);
  12. The glomerular filtration rate shall meet the following criteria: Subjects with mildrenal impairment (stage CKD2) : 60-89 mL/min (including values at both ends), subjectswith moderate renal impairment (stage CKD3) : 30-59 mL/min (including values at bothends), subjects with severe renal impairment (stage CKD4) : 15-29 mL/min (includingboth ends);
  13. Renal function was stable, and GFR results of two tests before administration (atleast 3 days apart) should be in the same CKD stage;
  14. Except for renal dysfunction and complications, the investigator judged that thephysical condition was good based on medical history inquiry, comprehensive physicalexamination, routine laboratory examination (blood routine, blood biochemistry, urineroutine, coagulation function, etc.), 12-lead electrocardiogram, chest X-ray (orthographic), abdominal B-ultrasound examination, etc.

Exclusion

Exclusion Criteria: Subjects meeting any of the following exclusion criteria will not be enrolled in this study

  1. Allergic constitution, including severe drug allergy or history of drug allergy, knownallergy to the study drug or any component of the study drug;
  2. Those who donated blood ≥400 mL within 3 months before screening, or donated blood ≥200 mL within 1 month before screening, or received blood transfusion or used bloodproducts;
  3. Patients with severe infection, trauma, gastrointestinal surgery or other majorsurgical operations within 4 weeks before screening;
  4. A history of difficulty swallowing or any gastrointestinal disorder affecting drugabsorption, including frequent nausea or vomiting due to any etiology;
  5. A strong or medium acting inducer or inhibitor of CYP3A enzyme, a strong P-gpinhibitor or P-gp inducer used within 1 month before screening;
  6. Those who had been vaccinated within 14 days prior to screening or planned to bevaccinated during the study period;
  7. Smokers who smoked at least 10 cigarettes a day in the 3 months before screening;
  8. had taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthinediet, chocolate) and/or had consumed excessive amounts of tea, coffee,grapefruit/grapefruit juice and/or caffeinated beverages (more than 8 cups of 200 mLper cup per day on average) in the 2 weeks prior to administration;
  9. A history of drug or substance abuse and/or alcoholism (14 units of alcohol per week: 1 unit = 285 mL for beer, 25 mL for spirits, or 100 mL for wine);
  10. had taken any products containing alcohol or had tested positive for alcohol breathtest within 24 hours before receiving the study drug;
  11. Positive urine drug screening (morphine, cannabis);
  12. Pregnant or lactating women or women of childbearing age who have tested positive forpregnancy;
  13. Active HBV or HCV infection, HIV-positive, or treponema pallidum antibody positive andrapid plasma response (RPR) positive (RPR only for treponema pallidum antibodypositive);
  14. Those not suitable for inclusion for other reasons; Subjects with normal renal function should be excluded if they meet any of thefollowing exclusion criteria:
  15. Participants who have participated in clinical trials of drugs or medical deviceswithin 3 months prior to screening (subject to drug acceptance);
  16. had taken any prescription drugs, over-the-counter drugs, any vitamin products orherbs in the 14 days prior to screening;
  17. Abnormal clinical laboratory examination with clinical significance, or otherclinically significant diseases (including but not limited to respiratory system,digestive system, urinary system, nervous system, blood system, endocrine system,tumor, immune, psychiatric or cardiovascular and cerebrovascular diseases) found byother clinical findings in the 12 months prior to screening; Subjects with renal impairment should be excluded if they meet any of the followingexclusion criteria:
  18. Participants who have participated in clinical trials of drugs or medical deviceswithin 1 month before screening (subject to drug acceptance);
  19. Patients with acute renal failure or who have had a kidney transplant; Or requirekidney dialysis during the study;
  20. In addition to the chronic primary renal disease itself and its complications, thosewho have suffered from or currently suffer from other serious systemic organ diseases,including but not limited to digestive system, respiratory system, nervous system,blood system, endocrine system, tumor, immune system, psychiatric or cardiovascularand cerebrovascular diseases, and are judged by the study doctor as unfit toparticipate in this study;
  21. hypertension that is not well controlled by antihypertensive medications (systolicblood pressure ≥150 mm Hg or diastolic blood pressure ≥100 mm Hg);
  22. Laboratory examination: alanine aminotransferase (ALT) ≥2×ULN, aspartateaminotransferase (AST) ≥2×ULN; Serum total bilirubin >1.5×ULN; Albumin <30 g/L;Neutrophil absolute value <1.3×109/L; Hemoglobin <60g/L; Platelet count <100×109/L;
  23. New York Heart Association (NYHA) Grade III or IV for congestive heart failure, orleft ventricular ejection fraction <50% at screening.

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: GST-HG171 Tablets
Phase:
Study Start date:
February 10, 2023
Estimated Completion Date:
March 01, 2024

Connect with a study center

  • The first hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

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