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A Phase I Open-label, Single-center Study to Assess the Effect of the CYP3A4 Inducer Rifampicin on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Volunteers Aged 18 to 45 Years

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Trial Profile

A Phase I Open-label, Single-center Study to Assess the Effect of the CYP3A4 Inducer Rifampicin on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Volunteers Aged 18 to 45 Years

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Selumetinib (Primary) ; Rifampicin
  • Indications Acute myeloid leukaemia; Colorectal cancer; Liver cancer; Malignant melanoma; Multiple myeloma; 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 Nov 2016 Results from NCT02093728 and NCT02046850 studies assessing safety and pharmacokinetics published in the European Journal of Clinical Pharmacology

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