NCT04297124

A Study to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects

A Phase 1, Single-Center, Open-Label Study, to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Celgene · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

CC-90009-CP-001 is a Phase 1, single-center, open-label, clinical pharmacology study to measure how much CC 90009 gets into the bloodstream, how much is eliminated in urine and stool, and how long it takes the body to get rid of it. In addition, the safety and tolerability of CC 90009 will be evaluated.

Detailed description

The primary objective of the study is to characterize the biotransformation and excretion of \[14C\]-CC-90009 following a single intravenous (IV) dose of 0.6 mg \[14C\]-CC-90009 in healthy male subjects. The secondary objective of the study is to evaluate the safety and tolerability. The total radioactivity of \[14C\]-CC-90009 will be 2 μCi.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	CC-90009	0.6 mg \[ 14C\]-CC-90009 administered IV as a single dose
RADIATION	[14C]	A single dose of \[ 14C\]-CC-90009 will contain approximately 2 µCi of radioactivity.

Timeline

• Start date: 2020-03-11
• Primary completion: 2021-06-04
• Completion: 2021-06-04
• First posted: 2020-03-05
• Last updated: 2021-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study