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NCT03135509 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03135509 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 16 participants.
The verdict
NCT03135509, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule formulation, after administration of single oral doses in healthy adult subjects under fasted conditions. Approximately 16 subjects will be assigned randomly to 1 of 2 treatment sequences. The sequences will dictate the order in which each subject receives the following treatments: * Treatment A (Reference): A single dose of 0.6 mg CC-220, administered as two 0.3-mg formulated CC-220 gelatin capsules. * Treatment B (Test): A single dose of 0.6 mg CC-220, administered as one 0.6-mg formulated CC-220 Hydroxypropyl methylcellulose (HPMC) capsule.
Interventions
- DRUG CC-220
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2017-06-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03135509
The ClinicalTrials.gov registry entry for NCT03135509 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 CC-220 is the first listed.
NCT03135509 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03135509 about?
NCT03135509 is a clinical study titled "A Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects". This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule formulation, after administration of single oral doses in healthy adult subjects under fasted conditions. Approximate...
What is the current status of trial NCT03135509?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2017-05-24. Estimated completion is 2017-06-28.
What interventions are being tested in trial NCT03135509?
The interventions under investigation include: CC-220 (DRUG).
Who is sponsoring clinical trial NCT03135509?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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