This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.
This is a clinical pharmacology study with 2 cohorts (subjects with severe HI by Child-Pugh criteria and matched healthy control subjects) to evaluate the PK, safety, and tolerability of a single oral dose of 30 mg quizartinib in otherwise healthy subjects with severe HI (as defined by Child-Pugh criteria). This study is planned to be conducted at up to 3 sites in the US, which use Child-Pugh criteria.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Participants will receive a single oral dose of 30 mg
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
RECRUITINGAdvanced Pharma
Miami, Florida, United States
RECRUITINGGCP Research
St. Petersburg, Florida, United States
RECRUITINGPharmacokinetic Parameter: Cmax
Maximum concentration, determined directly from individual concentration-time data
Time frame: From day of first dose, Day 1, through Day 29
Pharmacokinetic Parameter: Tmax
Time of the maximum concentration
Time frame: From day of first dose, Day 1, through Day 29
Pharmacokinetic Parameter: AUClast
Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear up log down
Time frame: From day of first dose, Day 1, through Day 29
Pharmacokinetic Parameter: AUCinf
Area under the concentration-time curve from time-zero extrapolated to infinity
Time frame: From day of first dose, Day 1, through Day 29
Pharmacokinetic Parameter: t1/2
The observed terminal half-life
Time frame: From day of first dose, Day 1, through Day 29
Treatment Emergent Adverse Events
TEAEs are defined as new AEs that occur after the first dose of study drug
Time frame: From day of first dose, Day 1, up to 30 days after Day 29
Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
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