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

Sponsor

Haisco Pharmaceutical Group Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05916573

Collaborator

(none)

Enrollment

Location

Arms

4.4

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment	Drug: HSK16149	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 12, 2022

Actual Primary Completion Date :

Feb 27, 2023

Actual Study Completion Date :

Apr 26, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mild Renal Impairment	Drug: HSK16149 single oral adminiatration, 20mg
Experimental: Moderate Renal Impairment	Drug: HSK16149 single oral adminiatration, 20mg
Experimental: Severe Renal Impairment	Drug: HSK16149 single oral adminiatration, 20mg
Experimental: Normal Renal function	Drug: HSK16149 single oral adminiatration, 20mg

Outcome Measures

Primary Outcome Measures

Cmax [From the start to 72 hours after administration]
The maximun plasma concentration of HSK16149
AUC0-t [From the start to 72 hours after administration]
Area under the concentration-time curve from time zero to time of last quantifiable concentration
AUC0-inf [From the start to 72 hours after administration]
Area under the concentration-time curve from time zero extrapolated to infinite time

Secondary Outcome Measures

Tmax [From the start to 72 hours after administration]
Time of maximum concentration
t1/2 [From the start to 72 hours after administration]
half-life
CL [From the start to 72 hours after administration]
Plasma clearance
Vz [From the start to 72 hours after administration]
Volume of distribution associated with the terminal phase
Ae [From the start to 72 hours after administration]
Cumulative urinary recovery of unchanged drug
Fe [From the start to 72 hours after administration]
Cumulative urinary recovery fraction of unchanged drug
CLr [From the start to 72 hours after administration]
Renal clearance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 >2ULN, 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Sichuan University	Chengdu	Sichuan	China

Sponsors and Collaborators

Haisco Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haisco Pharmaceutical Group Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05916573

Other Study ID Numbers:

HSK16149-104

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Renal Insufficiency

Study Results

No Results Posted as of Jun 23, 2023