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

NCT06160622 | Completed Phase 1

• 1 other identifier: RAY1216-23-07
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of participants with drug-related adverse events as assessed by CTCAE v5.0

  Day 1 to Day12

Study Arms (2)

Experimental 1: participants with severe renal impairment

EXPERIMENTAL

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

Drug: Leritrelvir

Experimental 2: healthy participants

EXPERIMENTAL

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

Drug: Leritrelvir

Interventions

Leritrelvir DRUG

Oral

Experimental 1: participants with severe renal impairment; Experimental 2: healthy participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: September 26, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

CN (1)