Evaluating HSK21542 in patients with renal impairment

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

This study is testing how a new drug called HSK21542 works and its safety in people with different levels of kidney problems compared to those with healthy kidneys.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05947097 on ClinicalTrials.gov

What this trial studies

This open-label, single-dose study aims to assess the pharmacokinetics and safety of HSK21542 in individuals with varying degrees of renal impairment, including mild, moderate, and severe cases. Participants will be compared to matched control subjects who have normal renal function. The study will involve a thorough evaluation of how the drug is processed in the body, ensuring that the safety and efficacy are well understood in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 79 with mild to severe renal impairment who meet specific health criteria.

Not a fit: Patients with normal renal function or those with uncontrolled comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective treatment options for patients with renal impairment.

How similar studies have performed: While this study focuses on a specific drug and population, similar pharmacokinetic studies in renal impairment have shown promise in understanding drug safety and efficacy.

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 79 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 79 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. 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);
2. 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;
3. Have conditions that may affect drug absorption, distribution, metabolism, or excretion (e.g., disease, drugs or surgery);
4. Acute renal failure;
5. Smoking more than 5 cigarettes per day within 3 months prior to screening or smoking during the study;
6. 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;
7. Drug abuse history within 5 years prior to screening, or positive urine drug screen at screening;
8. 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;
9. Participation in another clinical trial within 3 months before screening;
10. Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening;
11. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 2 × upper limit of normal, or bilirubin \> 1.5 × upper limit of normal;
12. Have a positive result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or anti-treponema pallidum specific antibody;
13. A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
14. Not suitable for this study as judged by the investigator.

Where this trial is running

Jinan, Shandong

• Shandong Provincial Qianfoshan Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Wei Zhao, PhD — Qianfoshan Hospital
• Study coordinator: Meixia Chen, PhD

Conditions Renal Impairment