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

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

Official Title
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A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Severe Kidney Impairment on the Pharmacokinetics, Safety and Tolerability of Leritrelvir(RAY1216)

Conditions
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Kidney Impairment

Intervention / Treatment
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* Drug: Leritrelvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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) 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1: participants with severe renal impairment<br>8 participants with severe renal impairment will be given 400mg of Leritrelvir | Drug: Leritrelvir<br>* Oral<br>|
| Experimental: Experimental 2: healthy participants<br>8 participants with normal renal function will be given 400mg of Leritrelvir | Drug: Leritrelvir<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with drug-related adverse events as assessed by CTCAE v5.0 |  | Day 1 to Day12 |