A Randomized, Open-Label, Single Dose, Cross-Over Study To Investigate The Bioequivalence Of Three RO5424802 Test Formulations Versus A Reference Formulation Following Oral Administration In Healthy Subjects

Trial Profile

A Randomized, Open-Label, Single Dose, Cross-Over Study To Investigate The Bioequivalence Of Three RO5424802 Test Formulations Versus A Reference Formulation Following Oral Administration In Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 20 Oct 2016

At a glance

  • Drugs Alectinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Pharmacokinetics
  • Sponsors Roche
  • Most Recent Events

    • 12 Mar 2016 Primary endpoint has not been met. (Ratio of geometric means (GMRs) for Cmax, AUClast, and AUC for 12.5% and 3% SLS formulation), as per results presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 12 Mar 2016 Primary endpoint has been met. (Ratio of geometric means (GMRs) for Cmax, AUClast, and AUC for 25% SLS formulation), as per results presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 12 Mar 2016 Results presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
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