Pharmacokinetics of VC005 Tablets in Subjects With Hepatic Impairment and Normal Hepatic Function

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-79
SponsorJiangsu vcare pharmaceutical technology co., LTD

About this trial

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 mild and moderate hepatic impairment compared to participants with normal hepatic function.

Eligibility criteria

Qualifiers

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 79 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).

Disqualifiers

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; or use of albumin within 14 days before the first dose of the study drug;

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;

Trial design

Treatments tested in this trial

  • VC005 Tablets

Treatment groups

24 Participants
are divided into 3 treatment groups