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A Phase 1, Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of Food On AG-120 Pharmacokinetics Following Single Oral Dose Administration To Healthy Subjects

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Trial Profile

A Phase 1, Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of Food On AG-120 Pharmacokinetics Following Single Oral Dose Administration To Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jan 2020

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At a glance

  • Drugs Ivosidenib (Primary)
  • Indications Acute myeloid leukaemia; Cholangiocarcinoma; Glioma; Myelodysplastic syndromes; Solid tumours
  • Focus Adverse reactions; 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 Mar 2019 Pooled data from 3 studies (NCT02579707, NCT02074839 and NCT02073994) presented at the 120th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
  • 28 Nov 2016 Status changed from active, no longer recruiting to completed.

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