Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males

Phase 1 Completed 31 enrolled Celgene Corporation Covance · collab

Non-randomizedCrossoverOpen-labelOther

Summary

To find out if the blood level of lenalidomide can be changed when a drug that prevents p-glycoprotein (a protein naturally present in the body that helps carry substances across cell membranes that is found in many parts of the body like the intestines, liver, and kidneys) from working (called a P-gp inhibitor) when taken together with lenalidomide. The study is also trying to find out if blood level of temsirolimus can be changed when a subject takes lenalidomide together with temsirolimus.

Timeline

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

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenalidomide	Other / unclassified	25 mg	Oral
Subject	Quinidine	Small molecule	600 mg	Oral
Subject	Temsirolimus	Small molecule	25 mg/ml	Intravenous
Background	Diphenhydramine	Unknown	25 mg	Intravenous

Indications

No indication recorded.