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NCT04459598 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants
A Phase 1 study, sponsored by Daiichi Sankyo Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04459598: Completed Phase 1 study, sponsored by Daiichi Sankyo Co..
NCT04459598 is a Phase 1 study that has completed, run by Daiichi Sankyo Co.. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04459598, a Phase 1 study, has completed, sponsored by Daiichi Sankyo Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This drug-drug interaction (DDI) study has been designed to investigate the effect of a moderate CYP3A inducer efavirenz on the pharmacokinetics of quizartinib and its major circulating active metabolite AC886.
Primary Outcome
Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration and was an observed value for the study. Cmax was assessed for Quizartinib and active metabolite AC886.
Interventions
- DRUG Quizartinib
- DRUG Efavirenz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-08-19 |
| Est. Completion | 2020-10-14 |
| Phase | Phase 1 |
What the finished NCT04459598 record still lists
NCT04459598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Quizartinib is the first listed.
NCT04459598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04459598 about?
NCT04459598 is a clinical study titled "A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants". This drug-drug interaction (DDI) study has been designed to investigate the effect of a moderate CYP3A inducer efavirenz on the pharmacokinetics of quizartinib and its major circulating active metabolite AC886.
What is the current status of trial NCT04459598?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-08-19. Estimated completion is 2020-10-14.
What interventions are being tested in trial NCT04459598?
The interventions under investigation include: Quizartinib (DRUG), Efavirenz (DRUG).
Who is sponsoring clinical trial NCT04459598?
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 NCT04459598's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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