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A Phase I, Open-label, Multi-center, Single-dose Study to Evaluate the Pharmacokinetics of ABL001 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function

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Trial Profile

A Phase I, Open-label, Multi-center, Single-dose Study to Evaluate the Pharmacokinetics of ABL001 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Jan 2023

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At a glance

  • Drugs Asciminib (Primary)
  • Indications Chronic myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Pharmacokinetics
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 13 Dec 2022 Results assessing the clinical impact of hepatic and renal impairment and of DDIs on the pharmacokinetics of asciminib and providing recommendations for eventual necessary dose adjustments, using data from NCT03605277 and NCT02857868, presented at the 64th American Society of Hematology Annual Meeting and Exposition
    • 11 Jun 2021 Results assessing pharmacokinetic (PK) profile of a single dose of asciminib (40 mg) in individuals with impaired renal function (based on absolute glomerular filtration rate; NCT03605277) or impaired hepatic function (based on Child-Pugh classification; NCT02857868), published in the Journal of Clinical Pharmacology.
    • 18 Jul 2017 Status changed from recruiting to completed.

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