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

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

October 1, 2012

Primary Completion Date

January 1, 2013

Study Completion Date

January 1, 2013

Conditions
Healthy
Interventions
DRUG

Lenalidomide

25 mg Lenalidomide capsule will be administered orally once in the first period, and once with Quinidine in the second period

DRUG

Quinidine

300 mg of Quinidine will be administered orally every 12 hours for 1 day followed by 600 mg of Quinidine administered orally every 12 hours for the next 4 consecutive days

DRUG

Temsirolimus

25 mg/mL injection of Temsirolimus will be given directly into the vein over 30 minutes once in the second period and once with Lenalidomide in the third period.

DRUG

Diphenhydramine

Just before Temsirolimus is given, 25 mg of Diphenhydramine (Benadryl) will be given directly into the vein to decrease chances of an allergic reaction to Temsirolimus.

Trial Locations (1)

75247

Covance Clinical Research Unit Dallas, Dallas

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Covance

INDUSTRY

lead

Celgene

INDUSTRY