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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
Lifestyle, including diet, has not changed significantly since leaving Japan
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 18
Awards & highlights

Study Summary

This trial studies how well Elafibranor is absorbed, distributed, and eliminated by the body in healthy Japanese and non-Asian people.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your lifestyle and diet have not changed much since leaving Japan.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Electrocardiogram
Percentage of Participants With Clinically Significant Changes in Physical Examination
Percentage of Participants With Clinically Significant Changes in Vital Signs
+2 more

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

IpsenLead Sponsor
344 Previous Clinical Trials
72,991 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
251 Previous Clinical Trials
54,368 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must potential participants possess to take part in this experiment?

"This clinical trial requires 48 test subjects of non-Asian descent, aged 18 to 55. In addition to providing consent, participants must be Japanese natives and have been living in Japan for no more than 10 years, with an unchanged lifestyle since their departure from the country. All medical evaluations, including laboratory tests and ECG monitoring will occur during screening before any treatments are administered. Lastly, both male and female applicants must agree to remain at the clinic for the necessary duration as well as return for follow-up examinations throughout the study period."

Answered by AI

To what extent is the current trial population engaged?

"Affirmative. The information on clinicaltrials.gov confirms that this research, which was originally posted on September 19th 2022, is currently searching for participants. 48 patients need to be enrolled from 1 medical centres."

Answered by AI

Is the age requirement for this trial limited to adults under 65 years of age?

"This clinical study is open to participants aged 18-55 years."

Answered by AI

What fundamental aims is this medical research endeavor hoping to address?

"This medical study will evaluate the Noncompartmental PK of Elafibranor and its Metabolite GFT1007: Maximum (peak) Observed Plasma Drug Concentration (Cmax), over a Day 1 to Day 18 time period. Secondary objectives include assessing Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings, Percentage of Participants With Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs), as well as determining the Number of Patients with clinically significant changes in Physical Examination findings."

Answered by AI

What risks could be associated with Cohort 2: Healthy Non-Asian Participants?

"Due to the limited data supporting efficacy and safety, Cohort 2: Healthy Non-Asian Participants was awarded a score of 1 on our team's scale."

Answered by AI

Are there still opportunities to participate in this clinical investigation?

"Affirmative, the research hosted on clinicaltrials.gov attests that this study is seeking participants. This medical trial was initially advertised on September 19th 2022 and has since been updated to reflect new information as of October 7th 2022. Currently, 48 patients are being enrolled at a single site."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Collaborative Neuroscience Research LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Collaborative Neuroscience Research LLC: < 48 hours
~19 spots leftby Mar 2025