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Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

NCT ID: NCT00187707

Last Updated: 2012-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-08-31

Brief Summary

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The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. Previously, we have recruited a cohort of healthy volunteers (Studies of Pharmacogenetics in Ethnically-diverse Populations, or SOPHIE) and have resequenced the coding region of a number of membrane transporter genes to identify genetic polymorphisms in these genes. We plan to take a genotype-to-phenotype approach to study the influence of specific polymorphisms in the intestinal transporters, such as the novel organic cation transporters 1 and 2 (OCTN1 and OCTN2) genes on the bioavailability of gabapentin in healthy subjects. Eligible subjects will have a single inpatient study visit, during which they will take a single dose of gabapentin, and provide blood and urine samples over the course of 36 hours (5 terminal elimination gabapentin half-lives) for pharmacokinetic analysis.

Detailed Description

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Detailed description pending

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Gabapentin

Subjects will take a single dose of 400 mg of gabapentin

Group Type OTHER

Gabapentin

Intervention Type DRUG

Subjects will take a single dose of 400 mg of gabapentin

Interventions

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Gabapentin

Subjects will take a single dose of 400 mg of gabapentin

Intervention Type DRUG

Other Intervention Names

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NEURONTIN

Eligibility Criteria

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Inclusion Criteria

* Subjects must have previously participated in the "SOPHIE" study.
* Subjects will be between the ages of 18 and 40 years old
* Subjects will have been selected as healthy by medical history questionnaire and screening blood work (CBC, Comprehensive Metabolic panel).
* Subjects will be taking no regular medications and will have normal renal function.

Exclusion Criteria

* Pregnant
* Have a new history indicating they are no longer healthy; 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), will be excluded.
* Taking a medication that could confound study results
* Do not consent to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Giacomini, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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1003

Identifier Type: -

Identifier Source: org_study_id