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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: Completed Phase 1 study, sponsored by Celgene.
NCT03983161 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Estimation of AUC from time zero to the last measured time point
Interventions
- DRUG Fedratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2023-01-05 |
| Phase | Phase 1 |
What the finished NCT03983161 record still lists
NCT03983161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Fedratinib is the first listed.
NCT03983161 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03983161's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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