Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: Gabapentin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Kathleen Giacomini, PhD, Principal Investigator, Affiliation: University of California, San Francisco
Overall contact:
Chaline Brown, PharmD, Phone: 415-476-6756, Email: brownc@pharmacy.ucsf.edu
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
bioavailabilty 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.
Clinical Details
Official title: Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
Study design: Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Chaline Brown, PharmD, Phone: 415-476-6756, Email: brownc@pharmacy.ucsf.edu
San Francisco General Hospital, San Francisco, California 94143, United States; Recruiting
Chaline Brown, PharmD, Phone: 415-476-6756, Email: brownc@pharmacy.ucsf.edu
Additional Information
Starting date: September 2005
Last updated: September 14, 2005
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