Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants
Public ClinicalTrials.gov record NCT05543369. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I, Single-Centre, Open-Label, Repeat Dose Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of Elafibranor in Healthy Japanese and Non-Asian Participants.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05543369
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 18, 2022
- Primary completion
- Mar 9, 2023
- Completion
- Mar 9, 2023
- Last update posted
- Feb 19, 2025
2022 – 2023
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Collaborative Neuroscience Research LLC | Long Beach | California | 90806 | — |
| Collaborative Neuroscience Research, LLC | Los Alamitos | California | 90720 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05543369, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 19, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05543369 live on ClinicalTrials.gov.