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NCT03290443 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
A Phase 1 study of Hepatic Impairment, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 5
- Study locations
NCT03290443: Completed Phase 1 study of Hepatic Impairment, sponsored by Celgene.
NCT03290443 is a Phase 1 study of Hepatic Impairment that has completed, run by Celgene. The registered enrollment target is 31 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (14% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03290443, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched healthy control 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 maximum observed plasma concentration
Conditions Studied
Interventions
- DRUG Enasidenib
Study Locations (5)
Florida
- Clinical Pharmacology of Miami, LLC - Miami
- Orlando Clinical Research Center OCRC - Orlando
Colorado
- DaVita Clinical Research - Lakewood
Minnesota
- DaVita Clinical Research - Minneapolis
Tennessee
- New Orleans Center of Clinical Research - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2017-09-21 |
| Est. Completion | 2018-10-26 |
| Phase | Phase 1 |
What the finished NCT03290443 record still lists
NCT03290443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (14% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Enasidenib is the first listed.
NCT03290443 lists 5 locations in 4 states (Florida, Colorado, Minnesota).
Frequently Asked Questions
What is clinical trial NCT03290443 about?
NCT03290443 is a clinical study titled "A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.". This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screen...
What is the current status of trial NCT03290443?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2017-09-21. Estimated completion is 2018-10-26.
What conditions does trial NCT03290443 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT03290443?
The interventions under investigation include: Enasidenib (DRUG).
Who is sponsoring clinical trial NCT03290443?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03290443 being conducted?
This trial has 5 study locations across Colorado, Florida, Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03290443's enrollment target sits among peer trials
31 20th of 48 higher than 29 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment 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.
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