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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.

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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

FieldValue
Enrollment Target 48 participants
Start Date 2022-09-19
Est. Completion 2023-03-10
Phase Phase 1

Sponsor

Ipsen

85 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.