Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187707
First received: September 14, 2005
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Healthy
Drug: Gabapentin

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin [ Time Frame: Gabapentin ] [ Designated as safety issue: No ]
    To evaluate the bioavailability of Gabapentin in healthy individuals


Enrollment: 30
Study Start Date: September 2005
Study Completion Date: August 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gabapentin
Subjects will take a single dose of 400 mg of gabapentin
Drug: Gabapentin
Subjects will take a single dose of 400 mg of gabapentin
Other Name: NEURONTIN

Detailed Description:

Detailed description pending

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187707

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathleen Giacomini, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187707     History of Changes
Other Study ID Numbers: 1003
Study First Received: September 14, 2005
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on April 17, 2014