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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
At a glance
Conditions
Where it's being run
3 sites across 1 statesStudy leadership
- Global Clinical Leader · STUDY_DIRECTOR · Daiichi Sankyo
Who to contact
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What this trial measures
- 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