NCT01474330

A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects

A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) Following Multiple Daily Doses in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Celgene · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pomalidomide	0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions
DRUG	Placebo	Placebo capsule

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-11-18
• Last updated: 2019-11-12

Locations

1 site across 1 country: United States