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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 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04231435
The ClinicalTrials.gov registry entry for NCT04231435 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT04231435 reports 0 study locations.
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.
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