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NCT03294603 · ClinicalTrials.gov registry record · Phase 1
Radiolabeled Study of CC-220 in Healthy Male Subjects
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03294603: Completed Phase 1 study, sponsored by Celgene.
NCT03294603 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03294603, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a single-center, open-label study to characterize the biotransformation and excretion of \[14C\]-CC-220 in healthy male subjects. Each subject will participate in screening, a treatment phase (including baseline), and a follow-up phone call. Subjects will be screened for eligibility. Subjects who have met all inclusion criteria and none of the exclusion criteria at screening will return to the study site on Day -1, and will be domiciled at the study site from Day -1 to Day 10. On Day 1, subjects will receive a single oral dose of 1 mg \[14C\]-CC-220 under fasted conditions. Blood, urine, and fecal samples will be collected throughout the study for pharmacokinetic (PK; inclusive of metabolite profiling / characterization), mass balance, and/or clinical laboratory assessments. Safety will be monitored throughout the study. Subjects will be discharged from the study site on Day 10 following completion of the scheduled study procedures and satisfactory safety review. Subjects will participate in a follow-up phone call within 5 to 7 days following discharge.
Primary Outcome
Total \[14C\]-RA in whole blood, plasma, urine, and feces (and vomit, if applicable) will be measured via AMS.
Interventions
- DRUG CC-220
- RADIATION [14C]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-09-11 |
| Est. Completion | 2017-10-16 |
| Phase | Phase 1 |
What the finished NCT03294603 record still lists
NCT03294603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which CC-220 is the first listed.
NCT03294603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03294603 about?
NCT03294603 is a clinical study titled "Radiolabeled Study of CC-220 in Healthy Male Subjects". This is a single-center, open-label study to characterize the biotransformation and excretion of \[14C\]-CC-220 in healthy male subjects. Each subject will participate in screening, a treatment phase (including baseline), and a follow-up phone call. Subjects will be screened for eligibility. Subject...
What is the current status of trial NCT03294603?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-09-11. Estimated completion is 2017-10-16.
What interventions are being tested in trial NCT03294603?
The interventions under investigation include: CC-220 (DRUG), [14C] (RADIATION).
Who is sponsoring clinical trial NCT03294603?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03294603's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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