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Recruiting

NCT Number: NCT07551570

Pharmacokinetics of VC005 Tablets in Subjects With Renal Impairment and Normal Renal 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 renal impairment compared to participants with normal renal function.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233000, China

Location status: Recruiting

Location contact

Huan Zhou

CONTACT

[email protected]

13665527160

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • 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).

Treatment and study plan

VC005 tablets

Drug

Oral single dose

Primary outcomes

  1. Area under the plasma concentration-time curve(AUC)

    Time frame: Day1-Day3

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day1-Day3

Study contacts

Contact information is provided by the study sponsor or research team.

xiaojuan lai

CONTACT

[email protected]

15358160458

Sponsors and collaborators

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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