An Open-label, Comparative Study to Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) (Hyd-Sulfate) Following Single Oral Dosing to Healthy Subjects and to Subjects With Mild, Moderate, and Severe Hepatic Impairment

Trial Profile

An Open-label, Comparative Study to Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) (Hyd-Sulfate) Following Single Oral Dosing to Healthy Subjects and to Subjects With Mild, Moderate, and Severe Hepatic Impairment

Completed
Phase of Trial: Phase I

Latest Information Update: 23 Aug 2017

At a glance

  • Drugs Selumetinib (Primary)
  • Indications Acute myeloid leukaemia; Biliary cancer; Colorectal cancer; Liver cancer; Malignant melanoma; Non-small cell lung cancer; Pancreatic cancer; Solid tumours; Thyroid cancer
  • 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
    • 26 Dec 2016 Results of two phase I studise including this study published in the Journal of Clinical Pharmacology
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