The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Specified dose on specified days
Syneos Health Clinical Research Services, Llc
Miami, Florida, United States
Fedratinib Pharmacokinetics: Estimation of maximum observed plasma concentration (Cmax)
Time frame: Up to 12 days
Fedratinib Pharmacokinetics: Estimation of area under the curve (AUC) calculated from time zero to t, where t is the timepoint of the last quantifiable concentration (AUC(0-T))
Time frame: Up to 12 days
Fedratinib Pharmacokinetics: Estimation of AUC calculated from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to 12 days
Incidence of Adverse Events (AEs)
Time frame: Up to 66 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 66 days
Number of participants with clinically significant changes in electrocardiogram parameters
Time frame: Up to 66 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 66 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 66 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 66 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 66 days
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Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 66 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 66 days