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An Open-Label, 2-Period, Fixed Sequence Study to Determine the Effect of Multiple Oral Doses of Itraconazole on the Single Dose Pharmacokinetics of AG 120 in Healthy Adult Subjects

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Trial Profile

An Open-Label, 2-Period, Fixed Sequence Study to Determine the Effect of Multiple Oral Doses of Itraconazole on the Single Dose Pharmacokinetics of AG 120 in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Apr 2019

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At a glance

  • Drugs Ivosidenib (Primary) ; Itraconazole
  • Indications Acute myeloid leukaemia; Cholangiocarcinoma; Glioma; Myelodysplastic syndromes; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Agios Pharmaceuticals

    • Most Recent Events

    • 23 Apr 2019 Results assessing the effect of ethnicity, food, and itraconazole (strong CYP3A4 inhibitor) on the pharmacokinetics of ivosidenib after single oral doses in healthy subjects from three phase 1 open-label studies (NCT03071770, NCT02579707, NCT02831972 ), published in the European Journal of Clinical Pharmacology.
    • 16 Nov 2018 Results presented at the 30th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
    • 23 Jan 2017 Status changed from recruiting to completed.

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