Pharmacokinetics of VC005 Tablets in Subjects With Renal Impairment and Normal Renal Function (NCT07551570) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Pharmacokinetics of VC005 Tablets in Subjects With Renal Impairment and Normal Renal Function
China32 participantsStarted 2026-04-30
Plain-language summary
This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with renal impairment compared to participants with normal renal function.
Who can participate
Age range
18 Years – 70 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
. Voluntarily sign the informed consent form prior to the trial, fully understand the trial content, procedures, and possible adverse reactions, and be able to complete the study in accordance with the protocol requirements;
. Participants (including their partners) are willing to have no pregnancy plan from screening until 3 months after the last study drug administration and voluntarily take effective contraceptive measures; and have no plans to donate sperm or eggs;
. Male and female participants aged 18 to 70 years (inclusive);
. Male participants weighing no less than 50.0 kg, female participants weighing no less than 45.0 kg. Body mass index (BMI) between 18 and 32 kg/m² (inclusive).
Exclusion criteria
. History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components;
. History of drug abuse, drug addiction and/or alcohol abuse (consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); positive results in drug abuse screening and alcohol screening;
. Blood donation or significant blood loss (\> 400 mL) within 3 months prior to screening; or plan to donate blood during the trial;
. Average daily smoking of more than 5 cigarettes within 3 months prior to screening; or inability to stop using any tobacco products during the trial;
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
Area under the plasma concentration-time curve(AUC）
. History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex;
. Known active bacterial, viral, fungal, parasitic infection or other infection, or any infectious event requiring antibiotic treatment or hospitalization (within 4 weeks prior to screening), or any acute infection within 2 weeks of baseline;
. History of dysphagia or, within 6 months prior to screening, any gastrointestinal conditions affecting drug absorption or excretion (e.g., reflux esophagitis, peptic ulcer, chronic diarrhea, chronic constipation), history of liver disease (regardless of cure), and history of surgery (e.g., gastrointestinal surgery and other major surgeries).