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An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease

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Trial Profile

An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease

Status: Withdrawn prior to enrolment
Phase of Trial: Phase IV

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Vedolizumab (Primary) ; Caffeine; Dextromethorphan; Losartan; Midazolam; Omeprazole
  • Indications Crohn's disease; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors Takeda

Most Recent Events

  • 23 Oct 2020 Status changed from suspended to withdrawn prior to enrolment.
  • 19 Dec 2019 Status changed from recruiting to suspended.
  • 19 Dec 2019 Planned End Date changed from 29 Jul 2019 to 1 Aug 2020.

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