Advanced Solid Tumors Clinical Trial
Official title:
A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors
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. ;
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