Quizartinib for Severe Hepatic Impairment

This study is looking at how the body processes a drug called quizartinib in people with severe hepatic impairment (liver problems). It will compare this to how healthy people process the drug. Participants will receive a single 30 mg dose of quizartinib. Researchers will measure how much of the drug is in your body over about a month to understand its pharmacokinetics (how the body absorbs, distributes, metabolizes, and excretes a drug). This helps determine if the drug needs to be given differently to people with liver issues. The study aims to enroll 12 participants between 18 and 75 years old, with a body mass index (BMI) between 18 and 37 kg/m2. The current recruitment status is unclear.

Study design
This is a clinical pharmacology study with two groups: people with severe liver impairment and healthy volunteers. It will involve about 12 participants.
What's involved
Participants will receive a single oral dose of quizartinib and have their blood levels of the drug measured from the day of the dose through Day 29.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for pharmacokinetic measurements from the day of the first dose through Day 29.

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NCT06740799

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Daiichi Sankyo
~12 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Quizartinib

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetic Parameter: Cmax
Measured over From day of first dose, Day 1, through Day 29
+4 more outcomes measured
Hepatic Impairment
3 sites across 1 states
Florida3
  • Global Clinical Leader · STUDY_DIRECTOR · Daiichi Sankyo
Daiichi Sankyo Contact for Clinical Trial Information
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  • Pharmacokinetic Parameter: CmaxFrom day of first dose, Day 1, through Day 29

    Maximum concentration, determined directly from individual concentration-time data

  • Pharmacokinetic Parameter: TmaxFrom day of first dose, Day 1, through Day 29

    Time of the maximum concentration

  • Pharmacokinetic Parameter: AUClastFrom day of first dose, Day 1, through Day 29

    Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear up log down

  • Pharmacokinetic Parameter: AUCinfFrom day of first dose, Day 1, through Day 29

    Area under the concentration-time curve from time-zero extrapolated to infinity

  • Pharmacokinetic Parameter: t1/2From day of first dose, Day 1, through Day 29

    The observed terminal half-life