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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06160622
Other study ID # RAY1216-23-07
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 26, 2023
Est. completion date December 12, 2023

Study information

Verified date January 2024
Source Guangdong Raynovent Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 12, 2023
Est. primary completion date December 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. 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); 2. Ability to understand and willingness to sign a written informed consent form; Participants with normal renal function only: 3. 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. 4. Glomerular filtration rate (GFR)= 90 mL/min 5. Age, BMI, and sex comparable to those of subjects of severe renal impairment Participants with severe renal impairment only: 6. Diagnosis of CKD at least 3 months 7. glomerular filtration rate (GFR)< 60 mL/min/1.73 m2 Exclusion Criteria: 1. 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. 2. Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months. 3. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test 4. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks Participants with severe renal impairment only: 5. Participants with acute renal failure, or a kidney transplant history; Or requiring renal dialysis during the study period; 6. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure = 160mm Hg or diastolic blood pressure = 100mm) 7. New York heart association (NYHA) class III or IV congestive heart failure 8. Alanine aminotransferase (ALT) = 2×ULN, aspartate aminotransferase(AST) = 2×ULN; Serum total bilirubin > 1.5×ULN;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Leritrelvir
Oral

Locations

Country Name City State
China The First Affiliated Hospital of Xiamen University Xiamen Fujian

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum observed plasma concentration (Cmax) The Cmax of a single dose of Leritrelvir in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared. 0~96 hours
Primary Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast) The AUClast of a single dose of Leritrelvir in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared. 0~96 hours
Secondary Number of participants with drug-related adverse events as assessed by CTCAE v5.0 Day 1 to Day12
See also
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