A Phase I, 2-panel, Open-label, Randomized, Cross-over Trial in Healthy Subjects to Investigate the Effect of TMC435 at Steady-state on the Pharmacokinetics of the Immunosuppressants Cyclosporine and Tacrolimus.

Trial Profile

A Phase I, 2-panel, Open-label, Randomized, Cross-over Trial in Healthy Subjects to Investigate the Effect of TMC435 at Steady-state on the Pharmacokinetics of the Immunosuppressants Cyclosporine and Tacrolimus.

Completed
Phase of Trial: Phase I

Latest Information Update: 13 Nov 2012

At a glance

  • Drugs Simeprevir (Primary) ; Ciclosporin; Tacrolimus
  • Indications Hepatitis C; Liver transplant rejection
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 01 Oct 2012 Results will be presented at the 63nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) according to a Medivir media release.
    • 10 Jan 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 23 Dec 2011 Actual patient number is 29 according to ClinicalTrials.gov.
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