Status:
COMPLETED
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment
Lead Sponsor:
Guangdong Raynovent Biotech Co., Ltd
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir(RAY1216)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06161259
Start Date
September 14 2023
End Date
October 7 2023
Last Update
December 7 2023
Active Locations (1)
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1
Bethune First Hospital of Jilin University
Changchun, Jilin, China