A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food

Trial Profile

A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food

Completed
Phase of Trial: Phase I

Latest Information Update: 05 Apr 2017

At a glance

  • Drugs Osimertinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Pharmacokinetics
  • Acronyms Study 5
  • Sponsors AstraZeneca
  • Most Recent Events

    • 05 Apr 2017 Last checked against ClinicalTrials.gov record.
    • 23 Dec 2016 Results of population pharmacokinetics (popPK) analysis and exposure-response (ER) analysis (n=780) using data from two patient studies (AURA- NCT01802632, AURA2- NCT02094261) and one healthy volunteer study (Study 5, NCT01951599), published in the British Journal of Clinical Pharmacology.
    • 18 Jun 2014 Status changed from active, no longer recruiting to completed; according to ClinicalTrials.gov record.
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