Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Gabapentin

• Registration Number: NCT00187707
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

Detailed description pending

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Primary Completion: 2007-01
• Study Completion: 2008-08
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	Subjects will take a single dose of 400 mg of gabapentin

Primary Outcome Measures

Name	Time	Method
Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin	Gabapentin	To evaluate the bioavailability of Gabapentin in healthy individuals

Trial Locations

Locations (1)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States