Absolute Bioavailability of Quizartinib (QSC203118)

  • Research type

    Research Study

  • Full title

    An Open Label Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects

  • IRAS ID

    290964

  • Contact name

    Yira Bermudez

  • Contact email

    ybermudez@dsi.com

  • Sponsor organisation

    Daiichi Sankyo, Inc

  • Eudract number

    2021-000198-10

  • Clinicaltrials.gov Identifier

    NCT04796831

  • Duration of Study in the UK

    0 years, 1 months, 8 days

  • Research summary

    Research Summary

    The Sponsor is developing the test medicine, Quizartinib, for the potential treatment of relapsed (come back after treatment) / refractory (did not respond to treatment) acute myelogenous leukaemia (AML, a type of blood cancer). AML progresses quickly and aggressively, and usually requires immediate treatment. Quizartinib is currently approved for treatment of relapsed/refractory AML in Japan. Quizartinib is also being developed to treat Myelodysplastic syndromes (MDS), another type of blood cancer.

    The study involves radiolabelling (labelling the test medicine with radioactive 14C) which is used to locate the test medicine within the body. The study will try to measure the amount of oral test medicine that enters the bloodstream (absolute oral bioavailability). It will also try to determine how much of the test medicine and a major breakdown product (metabolite) enters the bloodstream over time (pharmacokinetics - PK). Safety and tolerability will also be assessed.

    The study will consist of one study period involving up to eight healthy male volunteers. On Day 1, volunteers will receive an oral dose of the test medicine as two tablets, followed by a single 15-minute intravenous infusion of radiolabelled test medicine four hours later. To assess tolerability of the IV administration, dosing will be staggered. Blood, urine and faecal samples will be collected regularly from dosing until discharge. Volunteers will remain in the clinical unit until Day 22.

    Summary of Results

    Eight healthy males aged 18 – 55 took part in this study, between April and June 2021. All participants received a single dose of 60 milligrams (mg) quizartinib (the test medicine) in tablet form by mouth, on an empty stomach. Four hours later, and still on an empty stomach, participants received 50 micrograms (μg) of quizartinib with a radioactive tag through a needle in a vein.
    The amount of quizartinib available in the plasma (the fluid part of the blood) after participants received quizartinib by mouth was about 71% of the amount available in the plasma after quizartinib was administered into the vein. This means that about 71% of quizartinib reached the bloodstream when given by mouth, as a tablet. No side effects were seen during the study.
    This study helped researchers find out the amount of quizartinib that reaches the bloodstream when quizartinib is given by mouth as a tablet. Findings from this study may be used in other studies with quizartinib. Other studies for quizartinib are ongoing.

  • REC name

    London - Riverside Research Ethics Committee

  • REC reference

    21/LO/0192

  • Date of REC Opinion

    8 Mar 2021

  • REC opinion

    Favourable Opinion