NCT03950882已完成1 期
A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
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
- 17
- 试验地点
- 1
- 主要终点
- PK parameters of PXL770
研究概览
简要总结
This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
详细描述
The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Subjects have given written informed consent
- •Body mass index (BMI): ≥ 25 kg/m²
- •Hepatic steatosis (CAP ≥ 300)
- •Insulin-resistant but not diabetic subjects
- •Fasting plasma glucose <126 mg/dL
- •Glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73 m²]
- •Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males
- •Effective contraception
排除标准
- •Evidence of another form of liver disease
- •Evidence of liver cirrhosis
- •Evidence of hepatic impairment
- •Positive serologic evidence of current infectious liver disease
- •History of excessive alcohol intake
- •Acute cardiovascular disease with 24 weeks prior to screening
- •Uncontrolled high blood pressure
- •Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
- •Use of non-permitted concomitant medication
- •Pregnancy or lactation
研究组 & 干预措施
PXL770
Experimental
PXL770 500 mg once daily (QD) for 4 weeks
干预措施: PXL770 (Drug)
PXL770
Experimental
PXL770 500 mg once daily (QD) for 4 weeks
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
placebo once daily (QD) for 4 weeks
干预措施: PXL770 (Drug)
Placebo
Placebo Comparator
placebo once daily (QD) for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
PK parameters of PXL770
时间窗: Day 26
AUC : Area under the plasma concentration curve
次要结局
- Plasma PK parameters of PXL770(Day 27)
研究者
研究点 (1)
Loading locations...
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