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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01611467
The ClinicalTrials.gov registry entry for NCT01611467 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 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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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