Obesity & Overweight
Conditions
Brief 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.
Interventions
DRUGVCT220
Single oral dose of VCT220 40 mg administered after a standardized breakfast.
Sponsors
Vincentage Pharma Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) of VCT220 | 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 | 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
| Measure | Time frame |
|---|---|
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From dosing through safety follow-up (Day 7 ± 3 days) |
Countries
China
Outcome results
None listed