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

NCT01712828 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-11-08

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Edward O'Mara, MD · Celgene Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01712828 on ClinicalTrials.gov