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Drug-drug Interaction Study With Metformin and Imatinib

NCT01404715 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-04-10

No results posted yet for this study

Summary

This study will address the following question: Does imatinib influence the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that imatinib may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of metformin. 1. The investigators hypothesize that the addition of imatinib to metformin therapy will reduce the renal clearance (CLR) of metformin leading to increased plasma concentrations and risk for toxicities 2. Knowledge of the pharmacokinetic interaction profile of metformin with organic cation transporter inhibitors, such as imatinib, is important to help develop safer more effective drug therapy with reduced side effects.

Conditions

  • Healthy

Interventions

DRUG

Metformin

Subjects will be given an oral dose of 1000 mg of metformin followed by an oral dose of 850 mg for a grand total of 1850 mg in both study Arm 1 and study Arm 2.

DRUG

Imatinib

A single oral dose of 600 mg of imatinib

Sponsors & Collaborators

Principal Investigators

  • Kathleen Giacomini, Ph.D · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT01404715 on ClinicalTrials.gov