NCT07347808

A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients

A Phase 1, Single-Dose, Open-Label, Parallel-Group Pharmacokinetic Study of VCT220 in Subjects With Moderate Renal Impairment and Matched Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Vincentage Pharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 study is designed to evaluate the pharmacokinetics and safety of a single oral dose of VCT220 (other name: CX11) in subjects with moderate renal impairment compared with age-, sex-, and body mass index (BMI)-matched subjects with normal renal function. The results of this study will provide scientific evidence to support appropriate clinical dosing recommendations of VCT220 in subjects with renal impairment.

Detailed description

This is a single-center, single-dose, open-label, non-randomized, parallel-group Phase 1 study. Subjects with moderate renal impairment (absolute estimated glomerular filtration rate \[eGFR\] ≥30 and \<60 mL/min) and matched subjects with normal renal function (absolute eGFR ≥90 and \<130 mL/min) will be enrolled. Subjects will receive a single oral dose of VCT220 40 mg following a standardized breakfast. Pharmacokinetic blood samples will be collected up to 72 hours post-dose to characterize the plasma pharmacokinetics of VCT220 and its metabolite VCT289. Safety will be assessed through monitoring of adverse events, vital signs, physical examinations, laboratory tests, and electrocardiograms.

Conditions

• Obesity & Overweight

Interventions

Type	Name	Description
DRUG	VCT220	Single oral dose of VCT220 40 mg administered after a standardized breakfast.

Timeline

• Start date: 2025-12-25
• Primary completion: 2026-01-18
• Completion: 2026-02-18
• First posted: 2026-01-16
• Last updated: 2026-03-27

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study