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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: Completed Phase 1 study, sponsored by Celgene Corporation.
NCT02321644 is a Phase 1 study that has completed, run by Celgene Corporation. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maximum observed plasma concentration
Interventions
- DRUG CC-90001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-11 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT02321644 record still lists
NCT02321644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which CC-90001 is the first listed.
NCT02321644 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02321644's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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