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A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment

Primary Purpose

Renal Impairment

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HSK16149
Sponsored by
Haisco Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects with renal impairment(RI): Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions; 18 years to 75 years (inclusive), male and female; 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)); 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; Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator; 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); 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 : Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions; 18 years to 75 years (inclusive), male and female, age and sex must be matched with subjects with RI; 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)); 90≤GFR<130 mL/min; Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator; 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); Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration. Exclusion Criteria: Allergic to any component in HSK16149 capsules; Uncontrolled or unstable cardiovascular, respiratory, liver, gastrointestinal tract, endocrine, blood, mental/nervous, etc.Systemic diseases; Those who have committed suicide or suicidal tendency in the past, or those who have recurrent dizziness, headache, memory and cognitive impairment; 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; Acute renal failure; 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; 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; Have a history of drug abuse within 5 years before screening, or have a positive drug abuse screening; 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; Those who have participated in any clinical trials of drugs or medical devices within 3 months before screening (subject to administration). 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; One of ALT and/or AST >2*ULN, total bilirubin > 1.5* ULN and creatine kinase > 2*ULN during screening; Those who are positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody and treponema pallidum antibody; Female subjects who are pregnant or lactating or whose serum pregnancy results are positive during the screening period or during the trial; Subjects considered by the researcher to have any factors that are not suitable for participating in this trial.

Sites / Locations

  • West China Hospital of Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Mild Renal Impairment

Moderate Renal Impairment

Severe Renal Impairment

Normal Renal function

Arm Description

Outcomes

Primary Outcome Measures

Cmax
The maximun plasma concentration of HSK16149
AUC0-t
Area under the concentration-time curve from time zero to time of last quantifiable concentration
AUC0-inf
Area under the concentration-time curve from time zero extrapolated to infinite time

Secondary Outcome Measures

Tmax
Time of maximum concentration
t1/2
half-life
CL
Plasma clearance
Vz
Volume of distribution associated with the terminal phase
Ae
Cumulative urinary recovery of unchanged drug
Fe
Cumulative urinary recovery fraction of unchanged drug
CLr
Renal clearance

Full Information

First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05916573
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
April 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haisco Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild Renal Impairment
Arm Type
Experimental
Arm Title
Moderate Renal Impairment
Arm Type
Experimental
Arm Title
Severe Renal Impairment
Arm Type
Experimental
Arm Title
Normal Renal function
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HSK16149
Intervention Description
single oral adminiatration, 20mg
Primary Outcome Measure Information:
Title
Cmax
Description
The maximun plasma concentration of HSK16149
Time Frame
From the start to 72 hours after administration
Title
AUC0-t
Description
Area under the concentration-time curve from time zero to time of last quantifiable concentration
Time Frame
From the start to 72 hours after administration
Title
AUC0-inf
Description
Area under the concentration-time curve from time zero extrapolated to infinite time
Time Frame
From the start to 72 hours after administration
Secondary Outcome Measure Information:
Title
Tmax
Description
Time of maximum concentration
Time Frame
From the start to 72 hours after administration
Title
t1/2
Description
half-life
Time Frame
From the start to 72 hours after administration
Title
CL
Description
Plasma clearance
Time Frame
From the start to 72 hours after administration
Title
Vz
Description
Volume of distribution associated with the terminal phase
Time Frame
From the start to 72 hours after administration
Title
Ae
Description
Cumulative urinary recovery of unchanged drug
Time Frame
From the start to 72 hours after administration
Title
Fe
Description
Cumulative urinary recovery fraction of unchanged drug
Time Frame
From the start to 72 hours after administration
Title
CLr
Description
Renal clearance
Time Frame
From the start to 72 hours after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects with renal impairment(RI): Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions; 18 years to 75 years (inclusive), male and female; 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)); 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; Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator; 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); 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 : Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions; 18 years to 75 years (inclusive), male and female, age and sex must be matched with subjects with RI; 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)); 90≤GFR<130 mL/min; Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator; 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); Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration. Exclusion Criteria: Allergic to any component in HSK16149 capsules; Uncontrolled or unstable cardiovascular, respiratory, liver, gastrointestinal tract, endocrine, blood, mental/nervous, etc.Systemic diseases; Those who have committed suicide or suicidal tendency in the past, or those who have recurrent dizziness, headache, memory and cognitive impairment; 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; Acute renal failure; 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; 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; Have a history of drug abuse within 5 years before screening, or have a positive drug abuse screening; 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; Those who have participated in any clinical trials of drugs or medical devices within 3 months before screening (subject to administration). 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; One of ALT and/or AST >2*ULN, total bilirubin > 1.5* ULN and creatine kinase > 2*ULN during screening; Those who are positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody and treponema pallidum antibody; Female subjects who are pregnant or lactating or whose serum pregnancy results are positive during the screening period or during the trial; Subjects considered by the researcher to have any factors that are not suitable for participating in this trial.
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China

12. IPD Sharing Statement

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A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment

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