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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment and Healthy Female
• Intervention / Treatment: Drug: VC005 Tablets

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233000
      • The First Affiliated Hospital of Bengbu Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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;
2. 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;
3. Male and female participants aged 18 to 79 years (inclusive);
4. 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:

1. History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components;
2. 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;
3. 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;
4. 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;
5. History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex;
6. 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;
7. 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 renal disease (confirmed renal disease regardless of cure; if only laboratory abnormalities such as elevated creatinine, hematuria, etc., to be assessed by the investigator), and history of surgery (e.g., gastrointestinal surgery and other major surgeries).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Hepatic Impairment	Drug: VC005 Tablets; Oral single dose
Experimental: Mild Hepatic Impairment	Drug: VC005 Tablets; Oral single dose
Experimental: Normal Hepatic Function	Drug: VC005 Tablets; Oral single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve(AUC）	Day1-Day3
Maximum Observed Plasma Concentration (Cmax)	Day1-Day3

Collaborators and Investigators

• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
• Investigators: Principal Investigator: Huan Zhou, The First Affiliated Hospital of Bengbu Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2026
• Primary Completion (Actual): August 2, 2026
• Study Completion (Actual): August 14, 2026

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: VC005-108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No