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NCT04699877 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT04699877 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 17 participants.
The verdict
NCT04699877, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of gilteritinib in male and female participants with severe renal impairment compared to healthy male and female participants with normal renal function. This study also evaluated safety and tolerability of a single oral dose of gilteritinib in male and female participants with severe renal impairment and healthy male and female participants with normal renal function. Part 2 of the study (mild and moderate renal impairment) was not conducted based on the final pharmacokinetic findings from part 1 (severe renal impairment).
Interventions
- DRUG Gilteritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-01-28 |
| Est. Completion | 2022-07-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04699877
The ClinicalTrials.gov registry entry for NCT04699877 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 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 1 intervention - of which Gilteritinib is the first listed.
NCT04699877 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04699877 about?
NCT04699877 is a clinical study titled "A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function". The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of gilteritinib in male and female participants with severe renal impairment compared to healthy male and female participants with normal renal function. This study also evaluated safety and tolerability of a single ...
What is the current status of trial NCT04699877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2021-01-28. Estimated completion is 2022-07-18.
What interventions are being tested in trial NCT04699877?
The interventions under investigation include: Gilteritinib (DRUG).
Who is sponsoring clinical trial NCT04699877?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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