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NCT04310527 · ClinicalTrials.gov registry record · Phase 1
Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adults
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT04310527 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 28 participants.
The verdict
NCT04310527, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is an open-label, single-center, randomized, three-period, two-sequence crossover study in healthy adult subjects to occur at one site in the United States. This study will evaluate the relative Bioavailability (BA) of an enasidenib sprinkle formulation, compared to the reference tablet formulation, when taken in the fasted state. This study will also evaluate the Pharmacokinetics (PK) of the enasidenib sprinkle formulation after a single oral dose in the fed state to assess the food effect. The study will consist of a Screening phase, a Treatment phase, and a Follow-up phone call. Approximately 28 healthy adult subjects (males or non-pregnant females) will be enrolled.
Interventions
- DRUG Enasidenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2019-12-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04310527
The ClinicalTrials.gov registry entry for NCT04310527 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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.
NCT04310527 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04310527 about?
NCT04310527 is a clinical study titled "Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adults". This is an open-label, single-center, randomized, three-period, two-sequence crossover study in healthy adult subjects to occur at one site in the United States. This study will evaluate the relative Bioavailability (BA) of an enasidenib sprinkle formulation, compared to the reference tablet formula...
What is the current status of trial NCT04310527?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2019-10-09. Estimated completion is 2019-12-09.
What interventions are being tested in trial NCT04310527?
The interventions under investigation include: Enasidenib (DRUG).
Who is sponsoring clinical trial NCT04310527?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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