Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

Study Overview
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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

Official Title
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Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

Conditions
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Healthy

Intervention / Treatment
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* Drug: Gabapentin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gabapentin<br>Subjects will take a single dose of 400 mg of gabapentin | Drug: Gabapentin<br>* Subjects will take a single dose of 400 mg of gabapentin<br>* Other names: NEURONTIN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin | To evaluate the bioavailability of Gabapentin in healthy individuals | Gabapentin |