Your session is about to expire
← Back to Search
Cohort 1 : Healthy Japanese Participants for Healthy Subjects
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 belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- Collaborative Neuroscience Research LLC: < 48 hours
Share this study with friends
Copy Link
Messenger