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A Phase 1, 2-Part, Multicenter, Open-Label, 3-Arm Study to Determine the Effect of Enasidenib (CC-90007) on the Pharmacokinetics of Single Oral Doses of Caffeine, Dextromethorphan, Fexofenadine, Flurbiprofen, Midazolam, Omeprazole, Pioglitazone, and Rosuvastatin in Patients With Acute Myeloid Leukemia

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Trial Profile

A Phase 1, 2-Part, Multicenter, Open-Label, 3-Arm Study to Determine the Effect of Enasidenib (CC-90007) on the Pharmacokinetics of Single Oral Doses of Caffeine, Dextromethorphan, Fexofenadine, Flurbiprofen, Midazolam, Omeprazole, Pioglitazone, and Rosuvastatin in Patients With Acute Myeloid Leukemia

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Mar 2024

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At a glance

  • Drugs Enasidenib (Primary) ; Dextromethorphan; Digoxin; Flurbiprofen; Midazolam; Omeprazole; Pioglitazone; Rosuvastatin
  • Indications Acute myeloid leukaemia
  • Focus Pharmacokinetics
  • Sponsors Celgene Corporation

    • Most Recent Events

    • 23 Feb 2024 Status changed from active, no longer recruiting to completed.
    • 06 Nov 2023 Planned End Date changed from 22 Sep 2023 to 16 Nov 2023.
    • 19 Jan 2022 Planned End Date changed from 21 Oct 2022 to 22 Sep 2023.

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