Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment

NCT06161259 | Completed Phase 1

• 1 other identifier: RAY1216-23-06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir(RAY1216)

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  The Cmax of a single dose of Leritrelvir in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.

  Day 1 to Day 4

• Area under the concentration-time curve from time zero to infinity (AUCinf)

  The AUCinf of a single dose of Leritrelvir in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.

  Day 1 to Day 4

• 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 impaired hepatic function and controls with normal hepatic function will be evaluated and compared.

  Day 1 to Day 4

Secondary Outcomes (1)

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

  Day 1 to Day 7

Study Arms (3)

Child-Pugh A

EXPERIMENTAL

8 participants with mild hepatic impairment (Child-Pugh A) will be given 400mg of Leritrelvir(RAY1216)

Drug: Leritrelvir(Ray1216)

Child-Pugh B

EXPERIMENTAL

8 participants with mild hepatic impairment (Child-Pugh B) will be given 400mg of Leritrelvir(RAY1216)

Drug: Leritrelvir(Ray1216)

Normal hepatic function

EXPERIMENTAL

8 participants with normal hepatic function will be given 400mg of Leritrelvir(RAY1216)

Drug: Leritrelvir(Ray1216)

Interventions

Leritrelvir(Ray1216) DRUG

Participants receive Leritrelvir orally.

Child-Pugh A; Child-Pugh B; Normal hepatic function

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥ 18 to ≤ 70 years, at the time of signing the informed consent.
• BMI ≥ 18 kg/m2 up to ≤ 32 kg/m2.
• Participants (including partners) must use reliable methods of contraception during the study and until 7 days following the last dose of investigational product.
• Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
• Participants with hepatic impairment only:
• Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available.
• Unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening, or treatment-naïve participants

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.
• QTcF (male) \> 470ms，QTcF (female) \> 480ms
• Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
• Participates 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
• Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening
• Participants with Normal Hepatic Function Only:
• Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.
• Participants with Hepatic Impairment Only:
• Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.
• Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Bethune First Hospital of Jilin University

Changchun, Jilin, China

Location

Related Publications (1)

• Li C, Mai J, Wu M, Zhang H, Li X, Li H, Li Y, Ding Y. Single-dose tolerability and pharmacokinetics of leritrelvir in Chinese patients with hepatic impairment and healthy matched controls. Antimicrob Agents Chemother. 2025 Feb 13;69(2):e0137724. doi: 10.1128/aac.01377-24. Epub 2024 Dec 17.

  PMID: 39688408 DERIVED

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 30, 2023
• First Posted: December 7, 2023
• Study Start: September 14, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 7, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-11

Locations

CN (1)