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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Elafibranor

• Registration Number: NCT05543369
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Study Start: 2022-09-19
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: Healthy Non-Asian Participants	Elafibranor	Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.
Cohort 1 : Healthy Japanese Participants	Elafibranor	Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.

Primary Outcome Measures

Name	Time	Method
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)	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)	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)	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)	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	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	Day 18	Cmax at steady state will be recorded from the PK blood samples collected.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs)	Baseline up to Day 19	An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs.
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 change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator.
Percentage of Participants With Clinically Significant Changes in Physical Examination	Baseline up to Day 19	Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings	Baseline up to Day 19	Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator.
Percentage of Participants With Clinically Significant Changes in Vital Signs	Baseline up to Day 19	Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.

Trial Locations

Locations (2)

Collaborative Neuroscience Research LLC; 🇺🇸 Long Beach, California, United States

Collaborative Neuroscience Research, LLC; 🇺🇸 Los Alamitos, California, United States