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NCT04459585 · ClinicalTrials.gov registry record · Early Phase 1
A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants
A Early Phase 1 study, sponsored by Daiichi Sankyo Co..
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT04459585: Completed Early Phase 1 study, sponsored by Daiichi Sankyo Co..
NCT04459585 is a Early Phase 1 study that has completed, run by Daiichi Sankyo Co.. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04459585, a Early Phase 1 study, has completed, sponsored by Daiichi Sankyo Co..
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the one-way drug-drug interaction potential of quizartinib on dabigatran etexilate in healthy adult participants.
Primary Outcome
Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration and was calculated using non-compartmental analysis.
Interventions
- DRUG Quizartinib
- DRUG Dabigatran Etexilate Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2020-10-20 |
| Phase | Early Phase 1 |
What the finished NCT04459585 record still lists
NCT04459585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Quizartinib is the first listed.
NCT04459585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04459585 about?
NCT04459585 is a clinical study titled "A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants". The purpose of this study is to investigate the one-way drug-drug interaction potential of quizartinib on dabigatran etexilate in healthy adult participants.
What is the current status of trial NCT04459585?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2020-08-28. Estimated completion is 2020-10-20.
What interventions are being tested in trial NCT04459585?
The interventions under investigation include: Quizartinib (DRUG), Dabigatran Etexilate Mesylate (DRUG).
Who is sponsoring clinical trial NCT04459585?
This trial is sponsored by Daiichi Sankyo Co., which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04459585's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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