Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03983161 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT03983161 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 39 participants.
The verdict
NCT03983161, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease.
Interventions
- DRUG Fedratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2023-01-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03983161
The ClinicalTrials.gov registry entry for NCT03983161 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 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 1 intervention - of which Fedratinib is the first listed.
NCT03983161 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03983161 about?
NCT03983161 is a clinical study titled "A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment". This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the su...
What is the current status of trial NCT03983161?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2019-09-04. Estimated completion is 2023-01-05.
What interventions are being tested in trial NCT03983161?
The interventions under investigation include: Fedratinib (DRUG).
Who is sponsoring clinical trial NCT03983161?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.