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NCT05543369 · ClinicalTrials.gov registry record · Phase 1
Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants
A Phase 1 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT05543369 is a Phase 1 study that has completed, run by Ipsen. The registered enrollment target is 48 participants.
The verdict
NCT05543369, a Phase 1 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study 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.
Interventions
- DRUG Elafibranor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2023-03-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05543369
The ClinicalTrials.gov registry entry for NCT05543369 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Elafibranor is the first listed.
NCT05543369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05543369 about?
NCT05543369 is a clinical study titled "Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants". 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 pati...
What is the current status of trial NCT05543369?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-09-19. Estimated completion is 2023-03-10.
What interventions are being tested in trial NCT05543369?
The interventions under investigation include: Elafibranor (DRUG).
Who is sponsoring clinical trial NCT05543369?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
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