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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
History of Changes

September 14, 2005
August 7, 2012
September 2005
January 2007   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00187707 on ClinicalTrials.gov Archive Site
Not Provided
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Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
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
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: Gabapentin
Subjects will take a single dose of 400 mg of gabapentin
Other Name: NEURONTIN
Gabapentin
Subjects will take a single dose of 400 mg of gabapentin
Intervention: Drug: Gabapentin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2008
January 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00187707
1003
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Kathleen Giacomini, PhD University of California, San Francisco
University of California, San Francisco
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP