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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.

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Trial Profile

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.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 May 2023

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At a glance

  • Drugs Elafibranor (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Ipsen

Most Recent Events

  • 08 May 2023 Status changed from recruiting to completed.
  • 10 Feb 2023 Planned End Date changed from 30 Jan 2023 to 30 Mar 2023.
  • 10 Feb 2023 Planned primary completion date changed from 30 Jan 2023 to 30 Mar 2023.

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