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NCT01611467 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects
A Phase 1 study of Safety and Pharmacokinetics in Healthy Volunteer Subjects, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01611467: Completed Phase 1 study of Safety and Pharmacokinetics in Healthy Volunteer Subjects, sponsored by Celgene.
NCT01611467 is a Phase 1 study of Safety and Pharmacokinetics in Healthy Volunteer Subjects that has completed, run by Celgene. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01611467, a Phase 1 study of Safety and Pharmacokinetics in Healthy Volunteer Subjects, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of \[14C\]-CC-223 solution in healthy male subjects; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 capsule containing a microtracer of \[14C\]-CC-223 solution in healthy male adult subjects Part 2: To evaluate the effect of a high-fat meal on the pharmacokinetics (PK) of CC-223 following a single 20-mg oral dose of CC-223 tablet; To evaluate the effect of a high-fat meal on the PK of M1, the principal pharmacologically-active metabolite, following a single 20-mg oral dose of CC-223 tablet; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 tablet in healthy male adult subjects.
Primary Outcome
Total \[14C\]-radioactivity in whole blood, plasma, urine and feces
Conditions Studied
Interventions
- DRUG CC-223
Study Locations (1)
Wisconsin
- Covance Research Unit, Inc - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-06-01 |
| Est. Completion | 2012-07-01 |
| Phase | Phase 1 |
What the finished NCT01611467 record still lists
NCT01611467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Safety and Pharmacokinetics in Healthy Volunteer Subjects appearing as the primary indexed condition, and to 1 intervention - of which CC-223 is the first listed.
NCT01611467 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01611467 about?
NCT01611467 is a clinical study titled "A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects". Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of \[14C\]-CC-223 solution in healthy male subjects; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 capsule contain...
What is the current status of trial NCT01611467?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-06-01. Estimated completion is 2012-07-01.
What conditions does trial NCT01611467 study?
This clinical trial studies the following conditions: Safety and Pharmacokinetics in Healthy Volunteer Subjects.
What interventions are being tested in trial NCT01611467?
The interventions under investigation include: CC-223 (DRUG).
Who is sponsoring clinical trial NCT01611467?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01611467 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01611467's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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