Metabolism and Excretory of HSK21542 in Maintenance Hemodialysis Patients
- Conditions
- Chronic Kidney Disease Patients
- Registration Number
- NCT06238388
- Lead Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria:<br><br> 1. Subjects who are willing to sign an informed consent form, fully understand the<br> objectives and purposes of the study, and are willing to comply with the study<br> protocol before any of the study-related procedures start.<br><br> 2. Age =18 years old, Male or female;<br><br> 3. Patients with end-stage renal diseases who receive hemodialysis (including<br> hemodiafiltration) 3 times in a week prior to screening for at least 3 months;<br><br> 4. Dry weight is 40.0-135.0 kg (inclusive) during the screening period;<br><br> 5. Patients with at least two occurrences of single-compartment urea clearance (sp<br> Kt/V) = 1.2, or at least two occurrences of urea reduction ratio (URR) = 65%, or one<br> occurrence of sp Kt/V = 1.2 and one occurrence of URR = 65% on different days of<br> dialysis within 6 months before administration;<br><br> 6. Female of childbearing age or Male must agree to adopt efficient contraceptive<br> measures in sexual intercourse during the study period and within 3 months after the<br> last administration; Menopausal female subjects should have had menopause at least<br> one year or should have had permanent sterilization (e.g., fallopian tube occlusion,<br> hysterectomy, bilateral salpingectomy).<br><br>Exclusion Criteria:<br><br> 1. Expected to undergo kidney transplantation and/or parathyroidectomy during the<br> study;<br><br> 2. History of allergy to opioids, such as urticaria (Note: adverse effects related to<br> opioid use, such as constipation and nausea, are not included as the exclusion<br> criteria in this study);<br><br> 3. Used opioids within 7 days before screening, or unable to avoid the use of opioids<br> other than the investigational product during the study;<br><br> 4. Participated in any clinical trial of other drug or medical device within 1 month<br> before screening (received study medication or treated by the medical device in the<br> clinical trial);<br><br> 5. Used blood perfusion during the screening period or expected study period;<br><br> 6. Blood pressure of upper limbs in the supine position at screening: systolic blood<br> pressure < 90 mmHg, or diastolic blood pressure < 60 mmHg, or systolic blood<br> pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg;<br><br> 7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)= 2.5 × upper<br> limit of normal (ULN), or total bilirubin = 2 × upper limit of normal (ULN) at<br> screening;<br><br> 8. Blood sodium > 155 mmol/L at screening;<br><br> 9. Blood donation (or loss) = 400 mL within the first 3 months of screening or<br> Hemoglobin < 80 g/L at screening;<br><br> 10. Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb),<br> syphilis antibody, or human immunodeficiency virus (HIV) antibody;<br><br> 11. Females who are pregnant or breastfeeding;<br><br> 12. Smoking an average of more than 5 cigarettes per day within the first 3 months of<br> screening, or not stopping the use of any tobacco products during the trial period;<br><br> 13. Any physiological or psychological diseases or conditions that may increase the risk<br> of the trial, affect the subject's compliance with the protocol, or affect the<br> subject's completion of the trial, as judged by the study physician, including but<br> not limited to:<br><br> 1. Known or suspected alcohol, anesthetic, or other substance abuse or drug<br> dependence history within the first 12 months of screening; Baseline urine drug<br> screening (if any) or positive alcohol breath test;<br><br> 2. severe systolic or diastolic heart failure within the first 6 months of<br> screening (e.g. NYHA grade IV congestive heart failure (NYHA heart function<br> grading criteria can be found in Appendix 3) ;<br><br> 3. Severe mental illness or cognitive impairment (e.g., dementia);<br><br> 4. Any other relevant acute or chronic neurological and psychiatric diseases<br> (e.g., encephalopathy, coma, delirium) within 3 months before screening And the<br> researchers believe it is not suitable for enrollment;<br><br> 5. Patients with malignant tumors, but not including: curable cervical carcinoma<br> in situ, skin basal cell carcinoma, or squamous cell carcinoma, or any other<br> tumor that has been cured (with no evidence of disease recurrence within 5<br> years).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative recovery of unchanged drug (Ae);Cumulative recovery fraction of unchanged drug (Fe);Plasma clearance;Cmax;AUC(0-t);AUC(0-8);Tmax;t1/2
- Secondary Outcome Measures
Name Time Method The main metabolites of HSK21542;Adverse events (AEs)