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Tyrosine Kinase Inhibitor

gilteritinib and 14C-labeled gilteritinib for Gilteritinib Pharmacokinetics

Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 15 - 46
Awards & highlights

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.

Eligible Conditions
  • Gilteritinib Pharmacokinetics
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 15 - 46
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 15 - 46 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in feces)
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in urine)
Excretion rate of 14C-labeled gilteritinib (radioactivity in feces)
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: gilteritinib and 14C-labeled gilteritinibExperimental Treatment2 Interventions
Gilteritinib will be taken once daily on study days 1 through 14 and days 16 through 47. On day 15, each participant will be given a single dose of 14C-labeled gilteritinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gilteritinib
FDA approved
Gilteritinib
FDA approved

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
122,348 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,859 Previous Clinical Trials
8,082,123 Total Patients Enrolled
~1 spots leftby Oct 2025
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