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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: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT04699877 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Area under the concentration-time curve from the time of dosing extrapolated to time infinity was derived from the plasma samples.
Interventions
- DRUG Gilteritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-01-28 |
| Est. Completion | 2022-07-18 |
| Phase | Phase 1 |
What the finished NCT04699877 record still lists
NCT04699877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Gilteritinib is the first listed.
NCT04699877 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04699877's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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