A Study of RAY1225 in Participants With Impaired Liver Function

Launched by GUANGDONG RAYNOVENT BIOTECH CO., LTD · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called RAY1225 to understand how it works in people with liver problems compared to healthy individuals. The goal is to find out how quickly RAY1225 enters the bloodstream and how long it stays in the body for those with liver impairment. The trial is currently looking for participants aged between 18 and 75 who have either mild to moderate liver issues or are healthy with normal liver function.

To be eligible for the study, participants need to meet certain criteria, such as having a body mass index (BMI) between 20 and 32 and not having any significant health issues that could affect the results. Participants will need to agree to use reliable birth control methods during the study and for six months afterward, and they must provide informed consent before joining. Those who participate can expect to undergo medical assessments and monitoring during the trial to ensure their safety and the effectiveness of the medication. This study is important as it may help develop better treatments for people with liver problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be ≥ 18 to ≤ 75 years;
• • 2. BMI ≥ 20 kg/m2 up to ≤ 32 kg/m2;
• • 3. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;
• • 4. 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;
• • 5. eGFR ≥ 60 mL/min/1.73 m2;
• Participants with Normal Hepatic Function Only:
• • 6. Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;
• Participants with hepatic impairment only:
• • 7. Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.
• 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\> 450ms;
• • 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;
• • 7. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
• Participants with Normal Hepatic Function Only:
• • 8. 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:
• • 9. 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.
• • 10. 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.