NCT02456883

Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors

A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Solid Tumors
• Pharmacokinetics of 14C-labeled Gilteritinib

Interventions

Type	Name	Description
DRUG	gilteritinib	oral
DRUG	14C-labeled gilteritinib	oral

Timeline

• Start date: 2016-03-04
• Primary completion: 2017-05-20
• Completion: 2017-06-19
• First posted: 2015-05-29
• Last updated: 2024-11-05

Locations

1 site across 1 country: United States