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NCT04702464 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT04702464: Completed Phase 1 study, sponsored by Celgene.
NCT04702464 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04702464, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This study is designed to test the effect of fluconazole (a dual CYP2C19 and CYP3A4 inhibitor) on the Pharmacokinetics (PK) of fedratinib. Knowledge of these effects can be used to determine if dose adjustments should be considered when fedratinib is coadministered with drugs that are dual CYP2C19 and CYP3A4 inhibitors. Subjects will be screened for eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will return to the clinical site on Day -1 for protocol-specified assessments, and will be domiciled at the clinical site from Day -1 to Day 27.
Primary Outcome
Maximum observed plasma concentration
Interventions
- DRUG Fluconazole
- DRUG Fedratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2021-01-12 |
| Est. Completion | 2021-05-13 |
| Phase | Phase 1 |
What the finished NCT04702464 record still lists
NCT04702464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluconazole is the first listed.
NCT04702464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04702464 about?
NCT04702464 is a clinical study titled "A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects". This study is designed to test the effect of fluconazole (a dual CYP2C19 and CYP3A4 inhibitor) on the Pharmacokinetics (PK) of fedratinib. Knowledge of these effects can be used to determine if dose adjustments should be considered when fedratinib is coadministered with drugs that are dual CYP2C19 a...
What is the current status of trial NCT04702464?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2021-01-12. Estimated completion is 2021-05-13.
What interventions are being tested in trial NCT04702464?
The interventions under investigation include: Fluconazole (DRUG), Fedratinib (DRUG).
Who is sponsoring clinical trial NCT04702464?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04702464's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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