This study will evaluate the impact of rapid acceleration in the heart rate on the QT prolongation of quizartinib.
This is a QT assessment study of quizartinib when given as a single oral dose of 90 mg in 70 healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Participants will receive a single oral dose of 90 mg
Participants will receive a single oral dose of 90 mg
WCT
San Antonio, Texas, United States
Change in Heart Rate
Time frame: Day 1 and Day 2
Treatment Emergent Adverse Events (TEAEs)
TEAEs are defined as new AEs that occur after the first dose of study drug, including 14 days after last dose of study drug" to end of the sentence
Time frame: From Day 1 up to the last day of Safety Follow-up (approximately 16 days)
Pharmacokinetic Parameter: Cmax
Maximum concentration, determined directly from individual concentration-time data
Time frame: Days 1, 2 and 3
Pharmacokinetic Parameter: Tmax
Time of the maximum concentration
Time frame: Days 1, 2 and 3
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: Days 1, 2 and 3
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