Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin

Overview[ - collapse ][ - ]

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.
ConditionHealthy
InterventionDrug: Gabapentin
PhaseN/A
SponsorUniversity of California, San Francisco
Responsible PartyUniversity of California, San Francisco
ClinicalTrials.gov IdentifierNCT00187707
First ReceivedSeptember 14, 2005
Last UpdatedAugust 7, 2012
Last verifiedAugust 2012

Tracking Information[ + expand ][ + ]

First Received DateSeptember 14, 2005
Last Updated DateAugust 7, 2012
Start DateSeptember 2005
Estimated Primary Completion DateAugust 2008
Current Primary Outcome MeasuresInfluence 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
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleInfluence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
Official TitleInfluence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
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.
Detailed Description
Detailed description pending
Study TypeInterventional
Study PhaseN/A
Study DesignEndpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
ConditionHealthy
InterventionDrug: Gabapentin
Subjects will take a single dose of 400 mg of gabapentin
Other Names:
NEURONTIN
Study Arm (s)Other: Gabapentin
Subjects will take a single dose of 400 mg of gabapentin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment30
Estimated Completion DateAugust 2008
Estimated Primary Completion DateJanuary 2007
Eligibility 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00187707
Other Study ID Numbers1003
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of California, San Francisco
Study SponsorUniversity of California, San Francisco
CollaboratorsNot Provided
Investigators Principal Investigator: Kathleen Giacomini, PhD University of California, San Francisco
Verification DateAugust 2012

Locations[ + expand ][ + ]

San Francisco General Hospital
San Francisco, California, United States, 94143