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

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

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 24 Nov 2017

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 Jun 2017 Status changed from not yet recruiting to recruiting.
    • 20 Jun 2017 Planned initiation date changed from 1 Feb 2017 to 1 Oct 2017.
    • 20 Jun 2017 Status changed from recruiting to not yet recruiting.
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