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Phase 1, Open-label, Partially Randomized, Parallel-group Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Single-dose Simeprevir (SMV), Odalasvir (ODV), and AL-335 Administered as a Fixed-dose Combination (FDC) Compared With the Single Agents Administered Together, and to Assess the Effect of Multiple-dose Lansoprazole or Omeprazole on the Single-dose Pharmacokinetics of SMV, ODV, and AL-335 Administered as an FDC

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Trial Profile

Phase 1, Open-label, Partially Randomized, Parallel-group Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Single-dose Simeprevir (SMV), Odalasvir (ODV), and AL-335 Administered as a Fixed-dose Combination (FDC) Compared With the Single Agents Administered Together, and to Assess the Effect of Multiple-dose Lansoprazole or Omeprazole on the Single-dose Pharmacokinetics of SMV, ODV, and AL-335 Administered as an FDC

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 16 Jan 2020

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At a glance

  • Drugs AL 335/odalasvir/simeprevir (Primary) ; Lansoprazole; Omeprazole
  • Indications Hepatitis C
  • Focus Pharmacokinetics
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 21 Dec 2017 Status changed from recruiting to discontinued.
    • 13 Jun 2017 Planned End Date changed from 10 Oct 2017 to 17 Oct 2017.
    • 13 Jun 2017 Planned primary completion date changed from 10 May 2017 to 17 Oct 2017.

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