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

NCT07551570 | Not Yet Recruiting Phase 1

• 1 other identifier: VC005-109
• Study Type: interventional
• Target: 32
• 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 renal impairment compared to participants with normal renal function.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (2)

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

  Day1-Day3

• Maximum Observed Plasma Concentration (Cmax)

  Day1-Day3

Study Arms (4)

Normal Renal Function

EXPERIMENTAL

Drug: VC005 Tablets

Mild Renal Impairment

EXPERIMENTAL

Drug: VC005 Tablets

Moderate Renal Impairment

EXPERIMENTAL

Drug: VC005 Tablets

Severe Renal Impairment

EXPERIMENTAL

Drug: VC005 Tablets

Interventions

VC005 Tablets DRUG

Oral single dose

Mild Renal Impairment; Moderate Renal Impairment; Normal Renal Function; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 70 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 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).

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;
• 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 liver disease (regardless of cure), 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

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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)