Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

NCT00187707 | Completed DMC

• 1 other identifier: 1003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

  To evaluate the bioavailability of Gabapentin in healthy individuals

  Gabapentin

Study Arms (1)

Gabapentin

OTHER

Subjects will take a single dose of 400 mg of gabapentin

Drug: Gabapentin

Interventions

Gabapentin DRUG

Subjects will take a single dose of 400 mg of gabapentin

Also known as: NEURONTIN

Gabapentin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kathleen Giacomini, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: August 1, 2008
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

US (1)