Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Severe Kidney Disease

NCT ID: NCT06160622

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2023-12-12

Brief Summary

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

Conditions

Kidney Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experimental 1: participants with severe renal impairment

8 participants with severe renal impairment will be given 400mg of Leritrelvir

Group Type: EXPERIMENTAL

Leritrelvir

Intervention Type: DRUG

Oral

Experimental 2: healthy participants

8 participants with normal renal function will be given 400mg of Leritrelvir

Group Type: EXPERIMENTAL

Leritrelvir

Intervention Type: DRUG

Oral

Interventions

Leritrelvir

Oral

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Countries

China

Other Identifiers

RAY1216-23-07

Identifier Type: -

Identifier Source: org_study_id