A Phase I, Single-Centre, Open-Label, Repeat Dose Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of Elafibranor in Healthy Japanese and Non-Asian Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Noncompartmental Pharmacokinetics (PK) of Elafibranor and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUCτ)
研究概览
简要总结
This study is intended to measure the blood levels of Elafibranor and one of its metabolites in Japanese and non-Asian Healthy Participants, to be able to compare how the body absorbs, distributes, and eliminates Elafibranor after Repeat Administration, in order to support inclusion of Japanese patients in the planned clinical studies with elafibranor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 : Healthy Japanese Participants
Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.
干预措施: Elafibranor (Drug)
Cohort 2: Healthy Non-Asian Participants
Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.
干预措施: Elafibranor (Drug)
结局指标
主要结局
Noncompartmental Pharmacokinetics (PK) of Elafibranor and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUCτ)
时间窗: Day 1 and Day 18
AUCτ will be recorded from the PK blood samples collected.
Noncompartmental PK of Elafibranor and its Metabolite GFT1007: Maximum (peak) Observed Plasma Drug Concentration (Cmax)
时间窗: Day 1 and Day 18
Cmax will be recorded from the PK blood samples collected.
Noncompartmental PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)
时间窗: Day 1 and Day 18
Tmax will be recorded from the PK blood samples collected.
Noncompartmental PK of Elafibranor and its Metabolite GFT1007: Trough Observed Plasma Concentration Before Dosing or at the end of the Dosing Interval (Ctrough)
时间窗: Day 1 and Day 18
Ctrough will be recorded from the PK blood samples collected.
Geometric Mean Ratios (GMR) of Elafibranor and and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUCτ) at Steady State
时间窗: Day 18
AUCτ at steady state will be recorded from the PK blood samples collected.
GMR of Elafibranor and and its Metabolite GFT1007: Maximum (peak) Observed Plasma Drug Concentration (Cmax) at Steady State
时间窗: Day 18
Cmax at steady state will be recorded from the PK blood samples collected.
次要结局
- Percentage of Participants With Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs)(Baseline up to Day 19)
- Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)(Baseline up to Day 19)
- Percentage of Participants With Clinically Significant Changes in Physical Examination(Baseline up to Day 19)
- Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings(Baseline up to Day 19)
- Percentage of Participants With Clinically Significant Changes in Vital Signs(Baseline up to Day 19)