Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04573582 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT04573582 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 40 participants.
The verdict
NCT04573582, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a multi-center, open-label study to assess the PK of single 100 mg oral doses of enasidenib (CC-90007) in subjects with mild, moderate, and severe hepatic impairment (HI), 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. Subjects will be enrolled in 4 Groups as follows: * Group A: Approximately 8 subjects with mild hepatic impairment (with a Child-Pugh score of \< 7) will be enrolled in Group A. * Group B: Approximately 8 subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group B. * Group C: Approximately 8 subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 15) will be enrolled in Group C. * Group D: Approximately 8-24 healthy subjects with normal hepatic function will be enrolled in Group D. Subjects in Group D will be matched to subjects in Groups A-C with respect to sex, age (± 10 years), and weight (± 30 pounds). More than 1 subject with differing degrees of HI can be matched to a single control; however, all subjects with HI must be matched to at least 1 healthy match subject.
Interventions
- DRUG Enasidenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2023-03-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04573582
The ClinicalTrials.gov registry entry for NCT04573582 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 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 Enasidenib is the first listed.
NCT04573582 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04573582 about?
NCT04573582 is a clinical study titled "Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment". This is a multi-center, open-label study to assess the PK of single 100 mg oral doses of enasidenib (CC-90007) in subjects with mild, moderate, and severe hepatic impairment (HI), and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined ...
What is the current status of trial NCT04573582?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2020-11-13. Estimated completion is 2023-03-08.
What interventions are being tested in trial NCT04573582?
The interventions under investigation include: Enasidenib (DRUG).
Who is sponsoring clinical trial NCT04573582?
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.