Drug Drug Interaction Study With Metformin and Imatinib
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborators:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01404715
First received: July 13, 2011
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy |
Drug: Metformin Drug: Metformin and Imatinib |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Pharmacokinetic Interaction Between Metformin and Imatinib in Healthy Volunteers. |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Investigate the effect of the co-administration of imatinib on the pharmacokinetics of metformin in healthy volunteers. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Cmax and Tmax will be determined from AUC-time curve Glomerular filtration rate (GFR) will be approximated by measured creatinine clearance using the following equation:GFR calculation: GFR = CLcreatinine = (Urinary creatinine * V) / (Plasma creatinine)
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metformin and Imatinib
Subjects will be dosed with Metformin alone and metformin in conjunction with imatinib
|
Drug: Metformin and Imatinib
Subjects will be given a single oral dose of 850 mg of metformin and a single oral dose of 600 mg of imatinib
Other Name: GLUCOPHAGE and GLEEVEC
|
|
Experimental: Metformin
Subjects will be dosed with Metformin alone (850mg)
|
Drug: Metformin
Subjects will be given a single oral dose of 850 mg of metformin
Other Name: GLUCOPHAGE
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404715
Locations
| United States, California | |
| Ucsf Ctsi Crc | |
| San Francisco, California, United States, 94143 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Kathleen Giacomini, Ph.D | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01404715 History of Changes |
| Other Study ID Numbers: | 6367, R01GM036780 |
| Study First Received: | July 13, 2011 |
| Last Updated: | September 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Drug drug interaction |
Additional relevant MeSH terms:
|
Metformin Imatinib Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013