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. |
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Condition | Healthy |
Intervention | Drug: Gabapentin |
Phase | N/A |
Sponsor | University of California, San Francisco |
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 |
Tracking Information[ + expand ][ + ]
First Received Date | September 14, 2005 |
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Last Updated Date | August 7, 2012 |
Start Date | September 2005 |
Estimated Primary Completion Date | August 2008 |
Current 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 |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin |
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Official Title | Influence 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 Type | Interventional |
Study Phase | N/A |
Study Design | Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science |
Condition | Healthy |
Intervention | Drug: 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 Status | Completed |
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Estimated Enrollment | 30 |
Estimated Completion Date | August 2008 |
Estimated Primary Completion Date | January 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00187707 |
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Other Study ID Numbers | 1003 |
Has Data Monitoring Committee | Yes |
Information Provided By | University of California, San Francisco |
Study Sponsor | University of California, San Francisco |
Collaborators | Not Provided |
Investigators | Principal Investigator: Kathleen Giacomini, PhD University of California, San Francisco |
Verification Date | August 2012 |
Locations[ + expand ][ + ]
San Francisco General Hospital | San Francisco, California, United States, 94143 |
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