A Phase I Open-label Trial in Healthy Volunteers to Evaluate the Exposure of Aramchol From Two Different Single Doses of an Aramchol Meglumine Tablet
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum observed peak concentration (Cmax) of Aramchol
研究概览
简要总结
Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine tablet.
详细描述
Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine given one daily with that from a 300 mg dose of Aramchol free acid tablets given twice daily in adult Healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This will be an open-label study
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy volunteers with body mass index (BMI) in the range of 18-30.9 kg/ m2 inclusive
- •Deemed healthy on the basis of clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
- •Agree to follow-up the contraception requirements of the trial
- •Able to give fully informed written consent
排除标准
- •Females of reproductive potential who are pregnant or lactating
- •Positive tests for hepatitis B, C or HIV
- •History of sever adverse reaction to any drug
- •Known sensitivity to drug medication
- •Drug or alcohol abuse
- •Smoking in the 3 months prior the study
- •Clinically relevant abnormal lab results, medical history or concurrent medical condition
- •Evidence of acute or chronic disease
- •Inability to adhere to study requirements
研究组 & 干预措施
Part B- Administration of Aramchol meglumine or Aramchol acid tablets
20 subjects will be randomized to Part B. Participants will receive Aramchol meglumine once daily for 10 days based on a dose predicted in Part A. Steady-state plasma concentration of Aramchol will be assessed.
干预措施: Aramchol (Drug)
Part A- Administration of Aramchol Meglumine tablet
12 subjects will be randomized to Part A. Participants will receive Aramchol meglumine tablet (test formulation) at 2 different single doses and plasma concentration will be assessed.
干预措施: Aramchol (Drug)
结局指标
主要结局
Maximum observed peak concentration (Cmax) of Aramchol
时间窗: 2 months
Blood samples will be collected for pharmacokinetics characterization. Cmax will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Time to reach maximum concentration (Tmax) of Aramchol
时间窗: 2 months
Blood samples will be collected for pharmacokinetics characterization. Tmax will be calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics
Area under the plasma curve (AUC) of Aramchol
时间窗: 2 months
Blood samples will be collected for pharmacokinetics characterization. AUC of Aramchol will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
次要结局
- Minimum observed concentration (Cmin) of Aramchol(2 months)
- Terminal elimination half life (T1/2) of Aramchol(2 months)
- Safety and tolerability of Aramchol(2 months)
- Average observed concentration (Cavg) of Aramchol(2 months)