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

NCT07551557 | Not Yet Recruiting Phase 1

• 1 other identifier: VC005-108
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatic Impairment and Healthy Female

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve(AUC）

  Day1-Day3

• Maximum Observed Plasma Concentration (Cmax)

  Day1-Day3

Study Arms (3)

Normal Hepatic Function

EXPERIMENTAL

Drug: VC005 Tablets

Mild Hepatic Impairment

EXPERIMENTAL

Drug: VC005 Tablets

Moderate Hepatic Impairment

EXPERIMENTAL

Drug: VC005 Tablets

Interventions

VC005 Tablets DRUG

Oral single dose

Mild Hepatic Impairment; Moderate Hepatic Impairment; Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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 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).

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233000, China

Location

Study Officials

• Huan Zhou

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaojuan lai

CONTACT

15358160458; lai_xiaojuan@vcarepharmatech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (1)