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Completed

NCT Number: NCT06161259

Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment

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

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bethune First Hospital of Jilin University

Changchun, Jilin, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

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.
  • 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

Treatment and study plan

Leritrelvir(Ray1216)

Drug

Participants receive Leritrelvir orally.

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Day 1 to Day 4

    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.

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

    Time frame: Day 1 to Day 4

    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.

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

    Time frame: Day 1 to Day 4

    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.

Secondary outcomes

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

    Time frame: Day 1 to Day 7

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 Hepatic 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
Dec 7, 2023

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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