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Effect of Genetic Variants in the Xenobiotic Transporter, OCT1, on Response to Metformin in Healthy Subjects
This study is currently recruiting participants.
Verified by University of California, San Francisco, September 2005
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187681
  Purpose

Specific Objectives:

  • To determine if individuals who carry a decreased or non-functional variant of OCT1 exhibit differences in the pharmacokinetics of metformin in comparison to individuals who carry the common allele.
  • To determine if individuals who carry the decreased or non-functional variants exhibit differences in the response to metformin in comparison to individuals who carry the common allele.

Condition Intervention
Healthy Volunteer
 Drug: Metformin HCl

Drug Information available for: Metformin Metformin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Previous participation in the SOPHIE study.
  • Between the ages of 18 and 40.
  • Posess a specific OCT1 genotype.

Exclusion Criteria:

  • Taking any medications other than vitamins
  • Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
  • Pregnant at time of study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187681

Contacts
Contact: Chaline Brown, PharmD 415-476-6756 brownc@pharmacy.ucsf.edu

Locations
United States, California
San Francisco General Hospital Recruiting
San Francsico, California, United States, 94143
Contact: Chaline Brown, PharmD     415-476-6756     brownc@pharmacy.ucsf.edu    
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathleen M Giacomini, PhD University of California, San Francisco
  More Information

Study ID Numbers: 865
Study First Received: September 13, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00187681  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Metformin
Healthy

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009



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