A Study to Evaluate the Pharmacokinetics of HSK21542 in Subjects With Renal Impairment

Sponsor

Haisco Pharmaceutical Group Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05947097

Collaborator

(none)

Enrollment

Location

Arms

8.2

Anticipated Duration (Months)

3.9

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 HSK21542 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: HSK21542 Injection	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Single-dose Study to Assess the Pharmacokinetics of HSK21542 Injection in Subjects With Varying Degrees of Renal Impairment Compared to the Control Subjects With Normal Renal Function

Actual Study Start Date :

Apr 24, 2023

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mild Renal Impairment	Drug: HSK21542 Injection 1ug/kg bolus for 2min±5s
Experimental: Moderate Renal Impairment	Drug: HSK21542 Injection 1ug/kg bolus for 2min±5s
Experimental: Severe Renal Impairment	Drug: HSK21542 Injection 1ug/kg bolus for 2min±5s
Experimental: Normal Renal function	Drug: HSK21542 Injection 1ug/kg bolus for 2min±5s

Outcome Measures

Primary Outcome Measures

Cmax [From the start to 240 hours after bolus]
The maximun plasma concentration of HSK21542
AUC0-t [From the start to 240 hours after bolus]
Area under the concentration-time curve from time zero to time of last quantifiable concentration
AUC0-inf [From the start to 240 hours after bolus]
Area under the concentration-time curve from time zero extrapolated to infinite time

Secondary Outcome Measures

Tmax [From the start to 240 hours after bolus]
Time of maximum concentration
t1/2 [From the start to 240 hours after bolus]
half-life
Vz [From the start to 240 hours after bolus]
Volume of distribution associated with the terminal phase
CL [From the start to 240 hours after bolus]
Plasma clearance
Ae [Predose and 72 hours after dosing]
Cumulative urinary recovery of unchanged drug
Fe [Predose and 72 hours after dosing]
Cumulative urinary recovery fraction of unchanged drug
CLr [Predose and 72 hours after dosing]
Renal clearance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 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 79 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 79 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:

Subjects who have a allergic to any component of HSK21542 injection or allergic history to opiates, such as urticaria (opiate-related adverse reactions such as constipation and nausea are not included as exclusion criteria in this study);
Have a history of severe and uncontrolled diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening;
Have conditions that may affect drug absorption, distribution, metabolism, or excretion (e.g., disease, drugs or surgery);
Acute renal failure;
Smoking more than 5 cigarettes per day within 3 months prior to screening or smoking during the study;
Average alcohol intake is more than 14 unit per week (1unit=17.7 mL alcohol , 1 unit=357mL 5% alcohol beer, or 43mL 40% alcohol spirit, or 147mL 12% alcohol wine) within the 3 months prior to screening, or taking any alcohol during study or a positive ethanol breath test at screening;
Drug abuse history within 5 years prior to screening, or positive urine drug screen at screening;
History of high consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) ,consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration;
Participation in another clinical trial within 3 months before screening;
Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening;
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 2 × upper limit of normal, or bilirubin > 1.5 × upper limit of normal;
Have a positive result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or anti-treponema pallidum specific antibody;
A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
Not suitable for this study as judged by the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong Provincial Qianfoshan Hospital	Jinan	Shandong	China	250014

Sponsors and Collaborators

Haisco Pharmaceutical Group Co., Ltd.

Investigators

Principal Investigator: Wei Zhao, PhD, Qianfoshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haisco Pharmaceutical Group Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05947097

Other Study ID Numbers:

HSK21542-104

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Additional relevant MeSH terms:

Renal Insufficiency

Study Results

No Results Posted as of Jul 17, 2023