NCT03802786已完成1 期
An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Imeglimin in Subjects With Moderate Hepatic Impairment Compared to Matched Healthy Control Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Poxel SA
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- PK parameters of imeglimin
研究概览
简要总结
This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Caucasian
- •BMI :18.0 and 40.0 kg/m2 and weight ≥50 kg.
- •Stable hepatic impairment or normal hepatic function for healthy volunteer
- •No clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (Subjects with moderate hepatic impairment may have medical findings consistent with their hepatic dysfunction)
- •Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
- •Informed consent signature
排除标准
- •Clinically relevant abnormal findings at the screening assessment
- •Severe adverse reaction to any drug or sensitivity to the trial medication or its componentsClinically significant vital signs outside the acceptable range at screening
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •Drug or alcohol abuse
- •Positive test HIV
- •Smoking more than 10 cig/day
- •Participation in other clinical trials of unlicensed or prescription medicines
- •Exclusion criteria for healthy volunteer
- •Positive test for HBV, HBC
- •eGFR less than 90 mL/min/1.73 m2
- •liver diseases
- •Exclusion criteria for hepatic impaired
- •eGFR less than 80 mL/min/1.73 m2
- •Hepatic impairment due to non liver disease
- •History of hepatocellular carcinoma or acute liver disease
- •CLinically significant change in liver disease status within 6 months
- •encephalopathy grade III or IV
研究组 & 干预措施
Moderate hepatic impairment
Experimental
Single dose of Imeglimin
干预措施: Imeglimin (Drug)
Normal hepatic function
Experimental
Single dose of Imeglimin
干预措施: Imeglimin (Drug)
结局指标
主要结局
PK parameters of imeglimin
时间窗: At Day 1
Cmax: peak plasma concentration after dosing
次要结局
- PK parameters of imeglimin(From day 1 to day 2)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](From day 1 to day 7)
研究者
研究点 (1)
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