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NCT02321644 · ClinicalTrials.gov registry record · Phase 1
Effect of UV Exposure on the PD of Multiple Doses of CC-90001 and Pilot Food Effect Study
A Phase 1 study, sponsored by Celgene Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT02321644 is a Phase 1 study that has completed, run by Celgene Corporation. The registered enrollment target is 26 participants.
The verdict
NCT02321644, a Phase 1 study, has completed, sponsored by Celgene Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a two-part, phase 1 study to evaluate the pharmacokinetics and pharmacodynamics of multiple doses of CC-90001 and the effects of food and formulation on the pharmacokinetics of single dose CC-90001 in healthy subjects. Part 1 involves the exposure of subjects to the minimum amount of UV-B light that causes minimally perceptible skin reddening. This will take place before dosing (baseline) and 3 times more while on increasing doses of CC-90001. Punch biopsies of the exposed areas will be taken and assessed for c-Jun terminal kinase activity. Part 2 involves evaluation of changes in pharmacokinetics of 2 formulations of CC-90001 when administered in the fasted state and after a high-fat meal.
Interventions
- DRUG CC-90001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-11 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02321644
The ClinicalTrials.gov registry entry for NCT02321644 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene Corporation, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CC-90001 is the first listed.
NCT02321644 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02321644 about?
NCT02321644 is a clinical study titled "Effect of UV Exposure on the PD of Multiple Doses of CC-90001 and Pilot Food Effect Study". This is a two-part, phase 1 study to evaluate the pharmacokinetics and pharmacodynamics of multiple doses of CC-90001 and the effects of food and formulation on the pharmacokinetics of single dose CC-90001 in healthy subjects. Part 1 involves the exposure of subjects to the minimum amount of UV-B li...
What is the current status of trial NCT02321644?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2014-11. Estimated completion is 2015-02.
What interventions are being tested in trial NCT02321644?
The interventions under investigation include: CC-90001 (DRUG).
Who is sponsoring clinical trial NCT02321644?
This trial is sponsored by Celgene Corporation, which has 40 total clinical trials registered on ClinicalTrials.gov.
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