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A Phase 1 Open-label, Radiolabeled, Single-dose Study To Investigate The Metabolism Of [14c]Lorlatinib (Pf-06463922) In Healthy Male Volunteers

Trial Profile

A Phase 1 Open-label, Radiolabeled, Single-dose Study To Investigate The Metabolism Of [14c]Lorlatinib (Pf-06463922) In Healthy Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 May 2020

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At a glance

  • Drugs Lorlatinib (Primary)
  • Indications Cancer; Neuroblastoma; Non-small cell lung cancer
  • Focus Pharmacokinetics
  • Sponsors Pfizer
  • Most Recent Events

    • 22 May 2020 Results from NCT03184168 and NCT02564562 evaluating Metabolism, Excretion, and Pharmacokinetics of Lorlatinib (PF-06463922) and Evaluation of the Impact of Radiolabel Position and Other Factors on Comparability, published in the Journal of Clinical Pharmacology
    • 16 Mar 2019 Comparison of data from the 2 ADME studies conducted for lorlatinib presented at the 120th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 11 Sep 2017 Status changed from recruiting to completed.
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