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NCT02049528 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02049528 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 18 participants.
The verdict
NCT02049528, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The study is being conducted to compare how long 2 oral formulations (a reference and a test formulation) of CC-122 stays in the body, and whether taking the test formulations with a high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in the study, one for each formulation and one for the test formulation + meal. The subjects will be asked to fast for at least 10 hours before taking the capsule formulations. During one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment sequence which will determine the order in which the subject will receive the reference formulation, the test formulation, and the test formulation + high-fat meal. Blood samples will be taken at intervals during the study to assess the amount of drug at those time points. Blood samples will also be collected at certain time points to determine the levels of special proteins that may help explain how CC-122 work.
Interventions
- DRUG CC-122
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-01-16 |
| Est. Completion | 2014-02-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02049528
The ClinicalTrials.gov registry entry for NCT02049528 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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-122 is the first listed.
NCT02049528 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02049528 about?
NCT02049528 is a clinical study titled "Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study". The study is being conducted to compare how long 2 oral formulations (a reference and a test formulation) of CC-122 stays in the body, and whether taking the test formulations with a high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in the study, one for each f...
What is the current status of trial NCT02049528?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2014-01-16. Estimated completion is 2014-02-08.
What interventions are being tested in trial NCT02049528?
The interventions under investigation include: CC-122 (DRUG).
Who is sponsoring clinical trial NCT02049528?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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