A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Selumetinib With Respect to an Intravenous Microdose of [14C] Selumetinib in Healthy Male Volunteers

Trial Profile

A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Selumetinib With Respect to an Intravenous Microdose of [14C] Selumetinib in Healthy Male Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 23 Aug 2017

At a glance

  • Drugs Selumetinib (Primary) ; Selumetinib (Primary)
  • Indications Acute myeloid leukaemia; Astrocytoma; Biliary cancer; Colorectal cancer; Glioma; Malignant melanoma; Multiple myeloma; Non-small cell lung cancer; Pancreatic cancer; Solid tumours; Thyroid cancer; Uveal melanoma
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca
  • Most Recent Events

    • 23 Aug 2017 Results of pooled population PK analysis using a non-linear mixed effects approach with plasma concentration data from n=346 subjects who received single oral doses of selumetinib 20-75 mg across ten Phase I studies (NCT01635023, NCT01974349, NCT02056392, NCT02063204, NCT02063230, NCT02093728, NCT02046850, NCT01960374, NCT02322749 and NCT02238782) published in the British Journal of Clinical Pharmacology
    • 10 Mar 2017 Results of pooled analysis of ten phase I studies including this study published in the European Journal of Clinical Pharmacology
    • 11 Oct 2016 Results of pooled analysis of PK data from this and other 9 trials ( NCT01635023, NCT01974349, NCT02056392, NCT02322749, NCT02063204, NCT02063230, NCT02093728, NCT02046850, NCT01960374) presented at the 41st European Society for Medical Oncology Congress
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