Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

May 10, 2013 updated by: XenoPort, Inc.

An Open-label, Randomized, Single Dose, Five-period Crossover Study to Evaluate the Relative Bioavailability of Different Formulations of GSK1838262 in Healthy Volunteers.

The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, randomized, single-dose, five-period, crossover study to evaluate the relative drug concentrations with different formulations of GSK1838262 in healthy volunteers. Four new formulations will be tested against the current formulation to identify the most promising new formulations for further development. Each subject will participate in five dosing periods and each period will be separated by at least seven days. Blood and urine samples will be collected over the 36 hour period following each dose administration to measure the drug concentrations.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Evansville, Indiana, United States, 47710
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy, male and female subjects aged between 18 and 65 years old.
  • normal body weight.
  • normal ECG, vital signs and lab tests.
  • normal kidney function
  • agree to use acceptable contraceptive methods required.
  • capable of giving written informed consent.

Exclusion Criteria:

  • positive blood alcohol or urine drug test.
  • positive hepatitis B/C and HIV
  • donation of more than 450 mL blood within the 56 days.
  • sensitivity to gabapentin
  • pregnant or lactating females
  • smoker
  • certain medical conditions including heart disease, psychiatric disease, gastrointestinal disease, kidney or liver dysfunction
  • history of seizure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GSK1838262 arm
Each subject will participate in five dosing sessions separated by at least seven days. Subjects will receive a single dose of current formulation of GSK1838262 or one of the four new formulations of GSK1838262 at each dosing session in random sequence.
Drug: open label
This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
gabapentin concentrations in blood
Time Frame: measured up to 36 hr after dosing
measured up to 36 hr after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
gabapentin concentrations in urine
Time Frame: measured up to 36 hr after dosing
measured up to 36 hr after dosing
Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XenoPort, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 10, 2013

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 110882

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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