An Open Label Comparative Study of the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY 142886) (Hyd Sulfate) Following a Single Oral Dose in Subjects With Renal Impairment and Healthy Subjects

Trial Profile

An Open Label Comparative Study of the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY 142886) (Hyd Sulfate) Following a Single Oral Dose in Subjects With Renal Impairment and Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 23 Aug 2017

At a glance

  • Drugs Selumetinib (Primary)
  • Indications Acute myeloid leukaemia; Astrocytoma; Biliary cancer; Colorectal cancer; Glioma; Liver cancer; Malignant melanoma; Multiple myeloma; Neurofibromatoses; 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
    • 26 Dec 2016 Results of two phase I studies including this study published in the Journal of Clinical Pharmacology
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