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A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Moderate to Severe Crohn's Disease

Trial Profile

A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Moderate to Severe Crohn's Disease

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Nov 2019

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At a glance

  • Drugs Ustekinumab (Primary) ; Ustekinumab (Primary) ; Caffeine; Dextromethorphan; Midazolam; Omeprazole; Vitamin K; Warfarin
  • Indications Crohn's disease
  • Focus Pharmacokinetics
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 21 Oct 2019 Planned primary completion date changed from 24 Sep 2019 to 17 May 2022.
    • 21 Mar 2019 Planned End Date changed from 15 Oct 2021 to 17 May 2022.
    • 21 Feb 2019 Planned End Date changed from 10 Sep 2021 to 15 Oct 2021.
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