A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients

Vincentage Pharma Co., Ltd16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity & Overweight

Interventions

VCT220DRUG

Single oral dose of VCT220 40 mg administered after a standardized breakfast.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects aged 18 to 75 years * Body mass index (BMI) between 18.5 and 32.0 kg/m² * Able and willing to provide written informed consent * Willing to comply with contraception requirements * Moderate renal impairment group * Absolute eGFR ≥30 and \<60 mL/min * Diagnosis of chronic kidney disease for ≥3 months with stable renal function * Normal renal function group: Absolute eGFR ≥90 and \<130 mL/min Matched to moderate renal impairment subjects by sex, age (±10 years), and BMI (±10%) Exclusion Criteria: * History of hypersensitivity to GLP-1 receptor agonists or study drug components * History of hypoglycemia * History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 * History of pancreatitis * Clinically significant cardiovascular, hepatic, gastrointestinal, neurological, hematologic, endocrine, or psychiatric disease * Use of prohibited medications affecting drug metabolism prior to dosing * Positive tests for hepatitis B, hepatitis C, HIV, or syphilis * Pregnant or breastfeeding women

Locations (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Outcomes

Primary Outcomes

Maximum Plasma Concentration (Cmax) of VCT220

Time frame: Day 1 at 0 h prior to dosing and at 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 h (Day 2) ,36.0 h(Day 2) , 48.0 h (Day 3), and 72.0 h (Day 4) after dosing

Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC₀-t) of VCT220

Time frame: Day 1 at 0 h prior to dosing and at 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, and 24.0 h (Day 2) ,36.0 h(Day 2) , 48.0 h (Day 3), and 72.0 h (Day 4) after dosing

Secondary Outcomes

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From dosing through safety follow-up (Day 7 ± 3 days)

Data from ClinicalTrials.gov

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