This study is being done to compare the pharmacokinetics (PK) and safety/tolerability of tucatinib in healthy Japanese and Caucasian participants. Three cohorts of healthy Japanese and Caucasian men and women will be admitted to the Clinical Research Unit (CRU) and receive multiple oral doses of tucatinib over 14 days with and without food. Subjects will be in the study for up to 45 days, including the screening period. Due to practical considerations, each cohort will be dosed sequentially (this is not a dose escalation study).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Administered via oral tablet
PAREXEL International, Early Phase Clinical Unit - Los Angeles
Glendale, California, United States
Maximum observed concentration (Cmax) of tucatinib
Time frame: 14 days
Cmax of ONT-993
Time frame: 14 days
Time of the maximum observed concentration (tmax) of tucatinib
Time frame: 14 days
Tmax of ONT-993
Time frame: 14 days
AUC from time 0 to the time of last quantifiable concentration (AUClast) of tucatinib
Time frame: 14 days
AUClast of ONT-993
Time frame: 14 days
AUC from time 0 to 12 hours postdose (AUC0-12hr) of tucatinib
Time frame: 14 days
AUC0-12hr of ONT-993
Time frame: 14 days
AUC from time 0 extrapolated to infinity (AUC0-inf) of tucatinib
Time frame: 1 day
AUC from time 0 extrapolated to infinity (AUC0-inf) of ONT-993
Time frame: 1 day
Percentage of AUC0-inf due to extrapolation (%AUCextrap) of tucatinib
Time frame: 1 day
%AUCextrap of ONT-993
Time frame: 1 day
Apparent total clearance (CL/F) of tucatinib
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Time frame: 14 days
Apparent volume of distribution during the terminal phase (Vz/F) of tucatinib
Time frame: 14 days
Metabolite-to-parent molar ratio based on AUC (MRAUC) of ONT-993
Time frame: 14 days
Incidence of adverse events (AEs)
Time frame: 17 days