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NCT04231435 · ClinicalTrials.gov registry record · Phase 1
Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04231435: Completed Phase 1 study, sponsored by Celgene.
NCT04231435 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04231435, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a nonrandomized, fixed-sequence, open-label study to evaluate the effect of a single dose of fedratinib on the PK, safety, and tolerability of single doses of digoxin, rosuvastatin, and metformin in healthy subjects. The subjects will participate as follows: * Screening phase * Treatment phase (includes baseline) * Follow-up telephone call Subjects will be screened for eligibility during the screening phase. 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 through the morning of Day 22. During the study, blood samples will be collected at prespecified times for PK and PD. Urine samples will be collected at prespecified times for urinary PK evaluation of metformin. Subject safety will be monitored throughout the study.
Primary Outcome
Maximum observed plasma concentration
Interventions
- DRUG Metformin
- DRUG Rosuvastatin
- DRUG Digoxin
- DRUG Fedratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-12-18 |
| Est. Completion | 2020-02-21 |
| Phase | Phase 1 |
What the finished NCT04231435 record still lists
NCT04231435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT04231435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04231435 about?
NCT04231435 is a clinical study titled "Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin". This is a nonrandomized, fixed-sequence, open-label study to evaluate the effect of a single dose of fedratinib on the PK, safety, and tolerability of single doses of digoxin, rosuvastatin, and metformin in healthy subjects. The subjects will participate as follows: * Screening phase * Treatment ph...
What is the current status of trial NCT04231435?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-12-18. Estimated completion is 2020-02-21.
What interventions are being tested in trial NCT04231435?
The interventions under investigation include: Metformin (DRUG), Rosuvastatin (DRUG), Digoxin (DRUG), Fedratinib (DRUG).
Who is sponsoring clinical trial NCT04231435?
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 NCT04231435's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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