Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment

NCT ID: NCT06161259

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-14
• Study Completion Date: 2023-10-07

Brief Summary

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

Conditions

Hepatic Impairment

Study Design

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

Study Groups

Child-Pugh A

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

Group Type: EXPERIMENTAL

Leritrelvir(Ray1216)

Intervention Type: DRUG

Participants receive Leritrelvir orally.

Child-Pugh B

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

Group Type: EXPERIMENTAL

Leritrelvir(Ray1216)

Intervention Type: DRUG

Participants receive Leritrelvir orally.

Normal hepatic function

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

Group Type: EXPERIMENTAL

Leritrelvir(Ray1216)

Intervention Type: DRUG

Participants receive Leritrelvir orally.

Interventions

Leritrelvir(Ray1216)

Participants receive Leritrelvir orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participant must be ≥ 18 to ≤ 70 years, at the time of signing the informed consent.

BMI ≥ 18 kg/m2 up to ≤ 32 kg/m2.

2. Participants (including partners) must use reliable methods of contraception during the study and until 7 days following the last dose of investigational product.

3. 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:

4. Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available.

5. 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

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. QTcF (male) > 470ms，QTcF (female) > 480ms

3. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks

4. Participates who donated blood or bleeding profusely (> 400 mL) in the 3 months.

5. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test

6. Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening

Participants with Normal Hepatic Function Only:

7. 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:

8. 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.

9. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bethune First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39688408 (View on PubMed)

Other Identifiers

RAY1216-23-06

Identifier Type: -

Identifier Source: org_study_id