Status:
COMPLETED
Drug-drug Interaction Study With Metformin and Imatinib
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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...
Detailed Description
Screening Procedures: Prior to enrollment, subjects will be asked to come to the Clinical and Translational Science (CTSI) Clinical Research Centre (CRC) at San Francisco General Hospital (SFGH). The...
Eligibility Criteria
Inclusion
- Age 18-45 years
- Male or female
- If female, using appropriate contraception
- Healthy as judged by medical examination, medical history and normal biochemical and hematological measures
- Normal urinalysis and renal function
- Understand the nature and purpose of the study and provide informed consent
Exclusion
- Pregnant or lactating woman (female subjects will have a urine pregnancy test at the screening visit)
- Abnormal bone marrow function (leukocyte, neutrophil, or platelet counts outside the normal range)
- History of hypersensitivity or allergic reaction to metformin or imatinib
- Risk of congestive heart failure requiring pharmacologic treatment (medical history)
- History of renal or hepatic dysfunction (e.g., CLcr \<60mL/min, ALT \>80U/L, AST\>60 U/L) Anemic (hemoglobin \<12 g/dL)
- Use of any medications (including over the counter products, herbal products, or mineral supplements) with the exception of a daily vitamin or oral contraceptives. In particular use of medications that are known to interfere with the pharmacokinetics of metformin and imatinib such as cimetidine, cetirizine, ketoconazole, procainamide, St. John's Wort, and testosterone are prohibited.
- Subjects are undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function
- Laboratory parameters that are more than 2 standard deviations from the laboratory mean
- Subject carries a MATE1 gene variant that is predicted to effect MATE1 protein expression
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01404715
Start Date
October 1 2011
End Date
March 1 2013
Last Update
April 10 2014
Active Locations (1)
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1
Ucsf Ctsi Crc
San Francisco, California, United States, 94143