2-part Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of CC-220 & Effect of Food on CC-220 in Healthy Subjects

Phase 1 Completed 65 enrolled Celgene Corporation

RandomizedSingle-groupOpen-labelOther

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy subjects

Timeline

Start: 2012-11-01
Primary completion: 2013-10-09
Completion: 2013-10-09

Publications

Background Schafer PH, Ye Y, Wu L, Kosek J, Ringheim G, Yang Z, Liu L, Thomas M, Palmisano M, Chopra R. Cereblon modulator iberdomide induces degradation of the transcription factors Ikaros and Aiolos: immunomodulation in healthy volunteers and relevance to systemic lupus erythematosus. Ann Rheum Dis. 2018 Oct;77(10):1516-1523. doi: 10.1136/annrheumdis-2017-212916. Epub 2018 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iberdomide	Small molecule	0.03 mg	Oral
Subject	Iberdomide	Small molecule	0.1 mg	Oral
Subject	Iberdomide	Small molecule	0.3 mg	Oral
Subject	Iberdomide	Small molecule	1 mg	Oral
Subject	Iberdomide	Small molecule	2 mg	Oral
Subject	Iberdomide	Small molecule	4 mg	Oral
Subject	Iberdomide	Small molecule	6 mg	Oral

Indications

No indication recorded.