Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin - Full Text View

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187707

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 Volunteer	Drug: Gabapentin

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel 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:

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

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 bioavialbility 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)

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:	Kathleen Giacomini, Ph.D, UCSF
ClinicalTrials.gov Identifier:	NCT00187707 History of Changes
Other Study ID Numbers:	1003
Study First Received:	September 14, 2005
Last Updated:	March 24, 2011
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 February 09, 2012