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Completed

NCT Number: NCT06160622

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 ≥ 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;

Treatment and study plan

Leritrelvir

Drug

Oral

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: 0~96 hours

    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.

  2. Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)

    Time frame: 0~96 hours

    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.

Secondary outcomes

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

    Time frame: Day 1 to Day12

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2023
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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