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Cohort 1 : Healthy Japanese Participants for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Ipsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 18
Awards & highlights
No Placebo-Only Group

Summary

This trial tests how the drug Elafibranor is processed in the bodies of healthy Japanese and non-Asian people. Researchers measure blood levels of the drug and its byproducts over time. The goal is to ensure that Japanese patients can be safely included in future studies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
GMR of Elafibranor and and its Metabolite GFT1007: Maximum (peak) Observed Plasma Drug Concentration (Cmax) at Steady State
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
Noncompartmental PK of Elafibranor and its Metabolite GFT1007: Maximum (peak) Observed Plasma Drug Concentration (Cmax)
+3 more
Secondary study objectives
Electrocardiogram
Percentage of Participants With Clinically Significant Changes in Physical Examination
Percentage of Participants With Clinically Significant Changes in Vital Signs
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: Healthy Non-Asian ParticipantsExperimental Treatment1 Intervention
Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.
Group II: Cohort 1 : Healthy Japanese ParticipantsExperimental Treatment1 Intervention
Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elafibranor
2022
Completed Phase 1
~110

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

IpsenLead Sponsor
350 Previous Clinical Trials
74,277 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
260 Previous Clinical Trials
56,195 Total Patients Enrolled
~15 spots leftby Nov 2025
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