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NCT02456883 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02456883 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 6 participants.
The verdict
NCT02456883, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- DRUG gilteritinib
- DRUG 14C-labeled gilteritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2016-03-04 |
| Est. Completion | 2017-06-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02456883
The ClinicalTrials.gov registry entry for NCT02456883 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which gilteritinib is the first listed.
NCT02456883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02456883 about?
NCT02456883 is a clinical study titled "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...
What is the current status of trial NCT02456883?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2016-03-04. Estimated completion is 2017-06-19.
What interventions are being tested in trial NCT02456883?
The interventions under investigation include: gilteritinib (DRUG), 14C-labeled gilteritinib (DRUG).
Who is sponsoring clinical trial NCT02456883?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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