OCT1, on Response to Metformin in Healthy Subjects - Full Text View

Sponsor:	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
Other Conditions That May Be A Focus of Clinical Attention	Drug: Metformin HCl

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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Test whether genetic variants of the human organic cation transporter, OCT1, are associated with altered disposition or response to metformin. [ Time Frame: Approximately 60 hours ] [ Designated as safety issue: No ]
Do 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? Specially, we will test the hypothesis that the OCT1-expressing tissues are target organs for metformin, and that individuals with the variant transporters may have reduced metformin uptake into these sites (is this the correct meaning?) and therefore a reduced drug response to metformin

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
Metformin All subjects enrolled will be dosed with 2 doses of Metformin	Drug: Metformin HCl 2 doses of Metformin Day 1 1000mg, Day 2 850 mg Other Names: Dimethylguanylguanidine Glucophage

Eligibility

Criteria

Inclusion Criteria:

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

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:	Kathleen Giacomini, Ph.D, UCSF
ClinicalTrials.gov Identifier:	NCT00187681 History of Changes
Other Study ID Numbers:	865
Study First Received:	September 13, 2005
Last Updated:	March 30, 2011
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 February 12, 2012