Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Gabapentin
Subjects will take a single dose of 400 mg of gabapentin
Intervention: Gabapentin (Drug)
Outcomes
Primary Outcomes
Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
Time Frame: Gabapentin
To evaluate the bioavailability of Gabapentin in healthy individuals
Secondary Outcomes
No secondary outcomes reported