This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib while it is still in the body. Healthy participants will get one dose of tucatinib by mouth. Patients will be monitored for 8-14 days after they take the dose of tucatinib.
This study will examine the absorption, metabolism, and excretion of tucatinib in healthy individuals. Participants will receive one oral dose of tucatinib and will be followed for 8-14 days after the dose is received.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Single dose of 300 mg of \[¹⁴C\]-tucatinib containing approximately 150 μCi of \[¹⁴C\] radioactivity
Covance Clinical Research Unit
Madison, Wisconsin, United States
Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf])
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Time frame: Up to 14 days
AUC from time 0 to last quantifiable concentration
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Time frame: Up to 14 days
Maximum observed concentration
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Time frame: Up to 14 days
Time of maximum observed concentration
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Time frame: Up to 14 days
Apparent terminal elimination half-life
PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
Time frame: Up to 14 days
Apparent total clearance
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
Time frame: Up to 14 days
Apparent volume of distribution
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
Time frame: Up to 14 days
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AUC[0-inf] plasma tucatinib/total radioactivity ratio
AUC\[0-inf\] of plasma tucatinib relative to AUC\[0-inf\] of plasma total radioactivity
Time frame: Up to 14 days
AUC[0-inf] blood/plasma ratio
AUC\[0-inf\] of whole blood total radioactivity to AUC\[0-inf\] of plasma total radioactivity
Time frame: Up to 14 days
Amount excreted in urine (Aeu)
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
Time frame: Up to 14 days
Cumulative Aeu
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
Time frame: Up to 14 days
Percentage excreted in urine (Feu)
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
Time frame: Up to 14 days
Cumulative Feu
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
Time frame: Up 14 days
Renal clearance
PK outcome endpoint of tucatinib derived from urine collections
Time frame: Up to 14 days
Amount excreted in feces [Aef]
PK outcome endpoint of total radioactivity derived from feces collection
Time frame: Up to 14 days
Cumulative Aef
PK outcome endpoint of total radioactivity derived from feces collection
Time frame: Up to 14 days
Percentage excreted in feces [Fef]
PK outcome endpoint of total radioactivity derived from feces collection
Time frame: Up to 14 days
Cumulative Fef
PK outcome endpoint of total radioactivity derived from feces collection
Time frame: Up to 14 days
Relative abundance of tucatinib and its metabolites eliminated in urine and feces
Time frame: Up to 14 days
Relative abundance of tucatinib and its metabolites in plasma
Time frame: Up to 14 days
Incidence of adverse events (AEs)
Time frame: Up to 14 days