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Drug-Drug Interaction Study With Metformin and Nizatidine

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ClinicalTrials.gov Identifier: NCT01409395
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : April 10, 2014
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Metformin and nizatidine Drug: Metformin Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Pharmacokinetic Interaction Between Metformin and Nizatidine in Healthy Volunteers
Study Start Date : September 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metformin
Subjects will be dosed with Metformin alone (850 mg)
Drug: Metformin
Subjects will be given a single oral dose of 850 mg of metformin
Other Name: GLUCOPHAGE
Experimental: Metformin and Nizatidine
Subjects will be dosed with metformin in conjunction with nizatidine
Drug: Metformin and nizatidine
Subjects will be given a single oral dose of 850 mg of metformin and a single oral dose of 600 mg of nizatidine
Other Names:
  • Metformin: Fortamet, Glucophage
  • Nizatidine: Axid



Primary Outcome Measures :
  1. Composite of Pharmacokinetics of co-administration of nizatidine & metformin in healthy volunteers. [ Time Frame: 24 hours ]
    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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-45 years
  2. Male or female
  3. If female, using appropriate contraception
  4. Healthy as judged by medical examination, medical history and normal biochemical and hematological measures
  5. Normal urinalysis and renal function
  6. Understand the nature and purpose of the study and provide informed consent

Exclusion Criteria:

  1. Pregnant or lactating woman (female subjects will have a urine pregnancy test at the screening visit)
  2. Abnormal bone marrow function (leukocyte, neutrophil, or platelet counts outside the normal range)
  3. History of hypersensitivity or allergic reaction to metformin or nizatidine
  4. Risk of congestive heart failure requiring pharmacologic treatment (medical history)
  5. History of renal or hepatic dysfunction (e.g., CLcr <60mL/min, ALT >80U/L, AST>60 U/L)
  6. Anemic (hemoglobin <12 g/dL)
  7. 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 nizatidine such as cimetidine, cetirizine, ketoconazole, procainamide, St. John's Wort, and testosterone are prohibited.
  8. Laboratory parameters that are more than 2 standard deviations from the laboratory mean
  9. Subject carries a MATE2K gene variant that is predicted to effect MATE2K protein expression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409395


Locations
United States, California
Ucsf Ctsi Crc
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Kathleen M Giacomini, Ph.D University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01409395     History of Changes
Other Study ID Numbers: 6968
R01GM036780 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014

Keywords provided by University of California, San Francisco:
Drug drug interaction

Additional relevant MeSH terms:
Metformin
Nizatidine
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action