A Phase I, Open-Label, Randomised, Balanced, Single-Dose, Two-Period, Two-Sequence Crossover-Design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-marketed Tablet Formulation After Single Oral Administration in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) of Elafibranor: Area Under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t)
研究概览
简要总结
This study will evaluate the effects of food on how much test drug is able to access the circulation and reach the target area (known as bioavailability).
The test drug, elafibranor (IPN60190), is in development for the treatment of primary biliary cholangitis (PBC).
PBC is a rare, long-term autoimmune disease of the liver. An autoimmune disease occurs when the immune (defence) system treats healthy parts of the body as if they were foreign and attacks them.
This study will be in healthy volunteers, so this trial is not to test if the drug helps to improve health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Elafibranor Fasting then Elafibranor fed
Participants will receive Elafibranor 80 mg in Fasting State on Day 1 of Period 1 followed by a washout period of a maximum of 28 days. Participants will then receive Elafibranor 80 mg in Fed State on Day 1 of Period 2.
干预措施: elafibranor (Drug)
Elafibranor Fed then Elafibranor fasting
Participants will receive Elafibranor 80 mg in Fed State on Day 1 of Period 1 followed by a washout period of a maximum of 28 days. Participants will then receive Elafibranor 80 mg in Fasting State on Day 1 of Period 2.
干预措施: elafibranor (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of Elafibranor: Area Under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t)
时间窗: Day 1 up to Day 10
AUC0-t will be recorded from the PK blood samples collected.
PK of Elafibranor: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞)
时间窗: Day 1 up to Day 10
AUC0-∞ will be recorded from the PK blood samples collected.
PK of Elafibranor: Maximum Observed Plasma (peak) Drug Concentration (Cmax)
时间窗: Day 1 up to Day 10
Cmax will be recorded from the PK blood samples collected.
次要结局
- PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Half-life (t1/2)(Day 1 up to Day 10)
- PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)(Day 1 up to Day 10)
- Percentage of Participants With Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs)(Baseline up to Day 21)
- PK of Elafibranor's Metabolite GFT1007: Area under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t)(Day 1 up to Day 10)
- PK of Elafibranor's Metabolite GFT1007: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞)(Day 1 up to Day 10)
- PK of Elafibranor's Metabolite GFT1007: Maximum Observed Plasma (peak) Drug Concentration (Cmax)(Day 1 up to Day 10)
- PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Rate Constant (λz)(Day 1 up to Day 10)
- PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F)(Day 1 up to Day 10)
- Percentage of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings(Baseline up to Day 21)
- PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vd/F)(Day 1 up to Day 10)
- Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)(Baseline up to Day 21)
- Percentage of Participants With Clinically Significant Changes in Vital Signs(Baseline up to Day 21)
- Percentage of Participants With Clinically Significant Changes in Physical Examination(Baseline up to Day 21)