Organic Cation Transporter 1 (OCT1), on Response to Metformin in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187681
First received: September 13, 2005
Last updated: December 6, 2012
Last verified: December 2012
  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 Phase
Other Conditions That May Be A Focus of Clinical Attention
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Genetic Variants in the Xenobiotic Transporter, OCT1, on Response to Metformin in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Area Under the Curve (AUC) of Blood Concentration-time of Metformin [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours ] [ Designated as safety issue: No ]
    To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered pharmacokinetics of metformin, the difference in AUC of blood concentration-time of metformin between reference and variant groups will be measured.

  • Glucose Lowering Response to Metformin [ Time Frame: 0 to 180 minutes ] [ Designated as safety issue: No ]
    To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered glucose lowering response to metformin we will measure the difference in area under the glucose concentrations-time curve (Glucose AUC) following oral glucose tolerance test.


Enrollment: 20
Study Start Date: July 2003
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OCT1-variant Group
Subjects with OCT1-variant alleles will be dosed with 2 doses of Metformin
Drug: Metformin
2 doses of Metformin Day 1 1000mg, Day 2 850 mg
Other Names:
  • Dimethylguanylguanidine
  • Glucophage
Experimental: OCT1-reference Group
Subjects with OCT1-reference alleles will be dosed with 2 doses of Metformin
Drug: Metformin
2 doses of Metformin Day 1 1000mg, Day 2 850 mg
Other Names:
  • Dimethylguanylguanidine
  • Glucophage

  Show Detailed Description

  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 Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
  • Between the ages of 18 and 40.
  • Possess 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187681

Locations
United States, California
San Francisco General Hospital
San Francsico, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathleen M Giacomini, PhD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187681     History of Changes
Other Study ID Numbers: 865
Study First Received: September 13, 2005
Results First Received: May 20, 2011
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Healthy controls

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

ClinicalTrials.gov processed this record on August 28, 2014