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A Phase I, Open-Label, Randomized, 2-Treatment, 2-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule

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Trial Profile

A Phase I, Open-Label, Randomized, 2-Treatment, 2-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Feb 2023

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At a glance

  • Drugs Acalabrutinib (Primary) ; Acalabrutinib (Primary)
  • Indications B-cell lymphoma; B-cell prolymphocytic leukaemia; Bladder cancer; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Glioblastoma; Haematological malignancies; Head and neck cancer; Infections; Mantle-cell lymphoma; Multiple myeloma; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Richter's syndrome; Waldenstrom's macroglobulinaemia
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca

    • Most Recent Events

    • 22 Feb 2023 According to AstraZeneca media release, the Calquence (acalbrutinib) has been approved in the European Union (EU) for adults with chronic lymphocytic leukemia (CLL). The approval was based on the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on the results from the ELEVATE-PLUS trials.
    • 01 Nov 2022 Results from NCT04768985, NCT04488016 and NCT04564040; assessing a new Acalabrutinib Formulation That Enables Coadministration With Proton-Pump Inhibitors, published in the Clinical Pharmacology in Drug Development
    • 05 Aug 2022 According to an AstraZeneca media release, US FDA has approved new tablet formulation of CALQUENCE (acalabrutinib) for all current indications. The approval was based on results from this and two other phase I trials (ELEVATE PLUS).
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