Clinical trial NCT06577415: A Study of RAY1225 in Participants With Impaired Liver Function
Official title: A Single Dose Pharmacokinetic Study of ray1225 in Subjects With Varying Degrees of Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.


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.

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225
timeFrame: DAY1~43
measure: PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
timeFrame: DAY1~43
Secondary outcomes:
measure: Number of participants with drug-related adverse events as assessed by CTCAE v5.0
timeFrame: DAY1~43
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital,South Medical Hospital
state: Guangdong
Study officials:
References: