Assessing RAY1225 in patients with liver impairment

A Single Dose Pharmacokinetic Study of ray1225 in Subjects With Varying Degrees of Hepatic Impairment

This study tests how well a new medication called RAY1225 works in people with liver problems compared to those with healthy livers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Raynovent Biotech Co., Ltd (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06577415 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics of RAY1225, focusing on how quickly it enters the bloodstream and how efficiently the body eliminates it in individuals with impaired liver function compared to healthy participants. The trial includes adults aged 18 to 75 with either normal liver function or chronic mild to moderate liver impairment. Participants will be monitored for safety and efficacy throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with chronic mild to moderate liver impairment or healthy individuals with normal liver function.

Not a fit: Patients with severe liver impairment or significant allergic reactions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with liver impairment.

How similar studies have performed: While this specific approach is novel, similar studies assessing pharmacokinetics in liver-impaired populations have shown promise.

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.

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital,South Medical Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Zhongyuan XU

Conditions Hepatic Impairment