A Study of RAY1225 in Participants With Impaired Liver Function (NCT06577415) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225
Timeframe: DAY1~43
2
PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
. 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.