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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of VCT220
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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%)
排除标准
- •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
研究组 & 干预措施
Group A
Subjects with Moderate Renal Impairment (absolute eGFR ≥30 and <60 mL/min)
干预措施: VCT220 (Drug)
Group B
Subjects with Normal Renal Function Matched to Subjects with Moderate Renal Impairment (absolute eGFR ≥90 and <130 mL/min)
干预措施: VCT220 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of VCT220
时间窗: 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
时间窗: 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
次要结局
- Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(From dosing through safety follow-up (Day 7 ± 3 days))