RecruitingPhase 1

A Study of RAY1225 in Participants With Impaired Liver Function

China24 participantsStarted 2024-08-26

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Participant must be ≥ 18 to ≤ 75 years;
✓. BMI ≥ 20 kg/m2 up to ≤ 32 kg/m2;
✓. Participants (including partners) must use reliable methods of contraception during the study and until 6 months 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;
✓. eGFR ≥ 60 mL/min/1.73 m2;
✓. Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;
✓. Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.

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\> 450ms;
✕. 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;
✕. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
✕. Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.

What they're measuring

Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225

Timeframe: DAY1~43

PK: Maximum Observed Drug Concentration (Cmax) of RAY1225

Timeframe: DAY1~43

Trial details

NCT IDNCT06577415

SponsorGuangdong Raynovent Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-31

Contact for this trial

Zhongyuan XU

020-62786845 nfyygcp@126.com

View on ClinicalTrials.gov More Hepatic Impairment trials