Renal Impairment
Conditions
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.
Interventions
1ug/kg bolus for 2min±5s
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| CL | From the start to 240 hours after bolus | Plasma clearance |
| Ae | Predose and 72 hours after dosing | Cumulative urinary recovery of unchanged drug |
| Tmax | From the start to 240 hours after bolus | Time of maximum concentration |
| CLr | Predose and 72 hours after dosing | Renal clearance |
| Fe | Predose and 72 hours after dosing | Cumulative urinary recovery fraction of unchanged drug |
| 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 |
Countries
China
Contacts
Primary ContactMeixia Chen, PhD
Outcome results
None listed