An Open-label, Two-period, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics of Midazolam in CML Patients Who Are Resistant and/or Intolerant Against at Least One Prior Therapy With a BCR-ABL Tyrosine Kinase Inhibitor.

Trial Profile

An Open-label, Two-period, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics of Midazolam in CML Patients Who Are Resistant and/or Intolerant Against at Least One Prior Therapy With a BCR-ABL Tyrosine Kinase Inhibitor.

Completed
Phase of Trial: Phase I

Latest Information Update: 24 Nov 2014

At a glance

  • Drugs Nilotinib (Primary) ; Midazolam
  • Indications Chronic myeloid leukaemia
  • Focus Pharmacokinetics
  • Sponsors Novartis
  • Most Recent Events

    • 25 Feb 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 19 Nov 2013 Planned end date changed from 1 Sep 2014 to 1 Jan 2015 as reported by ClinicalTrials.gov.
    • 25 Apr 2013 Planned end date changed from 1 Dec 2013 to 1 Sep 2014 as reported by ClinicalTrials.gov.
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