NCT03294603

Radiolabeled Study of CC-220 in Healthy Male Subjects

A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of (14C)-CC-220 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Celgene · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	CC-220	1mg \[14C\]-CC-220 will be administered as a single dose
RADIATION	[14C]	Single dose of \[14C\]-CC-220 will contain approximately 1.4 μCi of radioactivity

Timeline

• Start date: 2017-09-11
• Primary completion: 2017-10-16
• Completion: 2017-10-16
• First posted: 2017-09-27
• Last updated: 2017-10-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study