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NCT03964038 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT03964038: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT03964038 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03964038, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib tablets under fasting conditions in healthy male and female participants.
Primary Outcome
AUC72 will be recorded from the PK plasma samples collected.
Interventions
- DRUG gilteritinib
- DRUG gilteritinib mini tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-05-21 |
| Est. Completion | 2019-07-16 |
| Phase | Phase 1 |
What the finished NCT03964038 record still lists
NCT03964038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which gilteritinib is the first listed.
NCT03964038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03964038 about?
NCT03964038 is a clinical study titled "A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects". The purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib tablets under fasting conditions in healthy male and female participants.
What is the current status of trial NCT03964038?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-05-21. Estimated completion is 2019-07-16.
What interventions are being tested in trial NCT03964038?
The interventions under investigation include: gilteritinib (DRUG), gilteritinib mini tablet (DRUG).
Who is sponsoring clinical trial NCT03964038?
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 NCT03964038's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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