This study is being done to look at how tucatinib might affect the way another drug (metformin) works. It will look at healthy volunteers and how tucatinib affects how the body absorbs metformin. This will help us find out whether tucatinib is safe to give together with metformin. The study will also look at how tucatinib affects how the kidneys work.
This is a single center, fixed-sequence, drug-drug interaction study to assess the effects of multiple oral doses of tucatinib on the pharmacokinetics of a single oral dose of metformin in healthy subjects. The primary objective of the study is to assess the effects of tucatinib on the single-dose PK of metformin. Secondary objectives of the study are to (1) assess the safety and tolerability of metformin when coadministered with tucatinib and (2) assess the effects of tucatinib on renal function using iohexol as glomerular filtration rate (GFR) marker.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Pharmaceutical Research Associates
Salt Lake City, Utah, United States
Maximum observed plasma concentration (Cmax) of metformin
Time frame: Up to 9 days
Time to maximum observed plasma concentration (tmax) of metformin
Time frame: Up to 9 days
Half-life (t1/2) of metformin
Time frame: Up to 9 days
Area under the plasma concentration-time curve from time 0 to the last available measurement (AUC0-last) of metformin
Time frame: Up to 9 days
Area under the plasma concentration time curve to time 0 extrapolated to infinity (AUC0-inf) of metformin
Time frame: Up to 9 days
Apparent volume of distribution (V2/F) of metformin
Time frame: Up to 9 days
Oral clearance (CL/F) of metformin
Time frame: Up to 9 days
Incidence of adverse events (as assessed by AE assessments, clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead electrocardiogram)
Time frame: Up to 16 days
Glomerular Filtration Rate (GFR) as measured by iohexol plasma clearance
Time frame: Up to 8 days
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