Effect of Genetic Variants in the Xenobiotic Transporter, OCT1, on Response to Metformin in Healthy Subjects - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effect of Genetic Variants in the Xenobiotic Transporter, OCT1, on Response to Metformin in Healthy Subjects

Official Title ^ICMJE

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Healthy Volunteer

Intervention ^ICMJE

Drug: Metformin HCl

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Chaline Brown, PharmD

415-476-6756

brownc@pharmacy.ucsf.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00187681

Responsible Party

Study ID Numbers ^ICMJE

865

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kathleen M Giacomini, PhD

University of California, San Francisco

Information Provided By

University of California, San Francisco

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP