Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

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

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 pending

Intervention(s) in this Clinical Trial

• Drug: Gabapentin

Primary Measures

• Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
  • Time Frame: Gabapentin
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of California, San Francisco Other

Overall Clinical Trial Officials and Contacts

Kathleen Giacomini, PhD Principal Investigator University of California, San Francisco  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00187707

Study ID Number: 1003

ClinicalTrials.gov Identifier: NCT00187707

Health Authority: United States: Institutional Review Board