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Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and day 18

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