Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

University of California San Francisco (UCSF)

Status

Completed

Conditions

Healthy

Treatments

Drug: Gabapentin

Study type

Interventional

Funder types

Other

Identifiers

NCT00187707

1003

Details and patient eligibility

About

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.

Full description

Detailed description pending

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.