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A Phase 1, Single-Dose, Open-Label Trial to Evaluate the Pharmacokinetics and Safety of AG-120 in Healthy Male Japanese Subjects Relative to Healthy Male Caucasian Subjects

Trial Profile

A Phase 1, Single-Dose, Open-Label Trial to Evaluate the Pharmacokinetics and Safety of AG-120 in Healthy Male Japanese Subjects Relative to Healthy Male Caucasian Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Apr 2019

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At a glance

  • Drugs Ivosidenib (Primary)
  • 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 Mar 2019 Results presented at the 120th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 09 Jan 2018 Status changed from active, no longer recruiting to completed.
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