Status:
COMPLETED
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Severe Kidney Disease
Lead Sponsor:
Guangdong Raynovent Biotech Co., Ltd
Conditions:
Kidney Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir.
Eligibility Criteria
Inclusion
- Body mass index (BMI) ≥19 to ≤28kg/m2 and total body weight \>50 kg(male) or \>40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- Ability to understand and willingness to sign a written informed consent form;
- Participants with normal renal function only:
- Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.
- Glomerular filtration rate (GFR)≥ 90 mL/min
- Age, BMI, and sex comparable to those of subjects of severe renal impairment
- Participants with severe renal impairment only:
- Diagnosis of CKD at least 3 months
- glomerular filtration rate (GFR)\< 60 mL/min/1.73 m2
Exclusion
- Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months.
- Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
- Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
- Participants with severe renal impairment only:
- Participants with acute renal failure, or a kidney transplant history; Or requiring renal dialysis during the study period;
- Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm)
- New York heart association (NYHA) class III or IV congestive heart failure
- Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin \> 1.5×ULN;
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06160622
Start Date
September 26 2023
End Date
December 12 2023
Last Update
February 2 2024
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China