Clinical trial NCT05916573: A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment
Official title: A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of HSK16149 in subjects with mild, moderate and severe renal impairment compared to the matched control subjects with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Subjects with renal impairment(RI):

  1. Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
  2. 18 years to 75 years (inclusive), male and female;
  3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height2 (m\^2));
  4. Subjects with medically stable RI until study completion corresponding to the classifications of Renal Function based on GFR: mild RI: 60≤GFR\<90 mL/min; moderate RI: 30≤GFR\<60 mL/min, severe RI:15≤GFR\<30 mL/min;
  5. Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator;
  6. Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for RI/ other comorbidities (last more than four weeks in good compliance);
  7. Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.
* Subjects with normal renal function :

  1. Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
  2. 18 years to 75 years (inclusive), male and female, age and sex must be matched with subjects with RI;
  3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg, weight must be matched with subjects with RI. Body mass index (BMI) : 18-30 kg/m\^2 (inclusive) (BMI= weight (kg)/height2 (m\^2));
  4. 90≤GFR\<130 mL/min;
  5. Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator;
  6. Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for comorbidities (last more than four weeks in good compliance);
  7. Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.

Exclusion Criteria:

1. Allergic to any component in HSK16149 capsules;
2. Uncontrolled or unstable cardiovascular, respiratory, liver, gastrointestinal tract, endocrine, blood, mental/nervous, etc.Systemic diseases;
3. Those who have committed suicide or suicidal tendency in the past, or those who have recurrent dizziness, headache, memory and cognitive impairment;
4. According to the researcher's judgment, there are factors that affect the absorption, distribution, metabolism and excretion of drugs, such as diseases, drugs, surgery, etc.; Taking Niaoduqing granules, the stool is irregular or shapeless;
5. Acute renal failure;
6. Smoking more than 5 cigarettes a day on average in the 3 months before screening or unable to stop using any tobacco products during the test period;
7. Drinking more than 14 units per week within 3 months before screening (1 unit = 17.7 mL ethanol, that is, 1 unit =357 mL beer with 5% alcohol content, 43 mL white wine with 40% alcohol content or 147 mL wine with 12% alcohol content), or those who can't ban alcohol during the test, or those who are positive in alcohol breath test;
8. Have a history of drug abuse within 5 years before screening, or have a positive drug abuse screening;
9. Those who have ingested beverages or foods rich in xanthine (coffee, tea, chocolate, etc.) or grapefruit for a long time in the past, or have taken any products rich in xanthine or grapefruit orally within 48 hours before administration;
10. Those who have participated in any clinical trials of drugs or medical devices within 3 months before screening (subject to administration).
11. The amount of blood donation (or blood loss) within 3 months before screening is ≥400 mL, or those who have received blood products to improve anemia;
12. One of ALT and/or AST \>2\*ULN, total bilirubin \> 1.5\* ULN and creatine kinase \> 2\*ULN during screening;
13. Those who are positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
14. Female subjects who are pregnant or lactating or whose serum pregnancy results are positive during the screening period or during the trial;
15. Subjects considered by the researcher to have any factors that are not suitable for participating in this trial.

Primary outcomes:
measure: Cmax
timeFrame: From the start to 72 hours after administration
measure: AUC0-t
timeFrame: From the start to 72 hours after administration
measure: AUC0-inf
timeFrame: From the start to 72 hours after administration
Secondary outcomes:
measure: Tmax
timeFrame: From the start to 72 hours after administration
measure: t1/2
timeFrame: From the start to 72 hours after administration
measure: CL
timeFrame: From the start to 72 hours after administration
measure: Vz
timeFrame: From the start to 72 hours after administration
measure: Ae
timeFrame: From the start to 72 hours after administration
measure: Fe
timeFrame: From the start to 72 hours after administration
measure: CLr
timeFrame: From the start to 72 hours after administration
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: