The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in particular, the routes of excretion and extent of metabolism of gilteritinib following administration of a single dose of 14C-labeled gilteritinib after repeated doses of gilteritinib. This study will also evaluate the safety of repeated oral administration of gilteritinib in subjects with advanced solid tumors as well as identify the metabolic profile of gilteritinib in plasma, urine and feces after a single oral dose of 14C-labeled gilteritinib.
Participants will be admitted for evaluation to the clinical research unit on day 14 for potentially up to 14 days (day 29). At approximately days 36 and 45 participants will return to the clinic (for 3 days) for additional sample collection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
oral
oral
Site US10001
Cleveland, Ohio, United States
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): AUCtau
Area under the concentration curve over the dosing interval (AUCtau)
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): Cmax
Maximum concentration (Cmax)
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): tmax
Time of maximum concentration (tmax)
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): t1/2
Terminal elimination half-life (t1/2)
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in whole blood): CL/F
Apparent body clearance after extravascular dosing (CL/F)
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): AUCtau
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): Cmax
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): tmax
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): t1/2
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity in plasma): CL/F
Time frame: Days 15 - 46
Pharmacokinetics of 14C-labeled gilteritinib (Radioactivity ratio of whole blood/plasma concentrations): AUC
Area under the concentration (AUC)
Time frame: Days 15 - 46
Excretion rate of 14C-labeled gilteritinib (radioactivity in urine)
Percent of dose excreted in urine
Time frame: Days 15 - 46
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in urine)
Cumulative total of radioactivity excreted in urine
Time frame: Days 15 - 46
Excretion rate of 14C-labeled gilteritinib (radioactivity in feces)
Percent of dose excreted in feces
Time frame: Days 15 - 46
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in feces)
Cumulative total of radioactivity excreted in feces
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): AUCtau
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): Cmax
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): tmax
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in plasma): CL/F
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in urine): Aetau
Cumulative amount of study drug excreted into urine from the time of dosing to the start of the next dosing interval (Aetau)
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in urine): CLR
Renal clearance (CLR)
Time frame: Days 15 - 46
Pharmacokinetics of gilteritinib (in urine): AETAU%
Percentage of study drug dose excreted into urine over the time interval between consecutive dosing (AETAU%)
Time frame: Days 15 - 46
Metabolite identification of gilteritinib in plasma, urine and feces
Time frame: Days 15 - 46
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