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Completed

NCT Number: NCT00833391

Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

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

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Key information

Conditions

Pharmacokinetics Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Evansville, Indiana, 47710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

open label

Drug

This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.

Primary outcomes

  1. gabapentin concentrations in blood

    Time frame: measured up to 36 hr after dosing

Secondary outcomes

  1. gabapentin concentrations in urine

    Time frame: measured up to 36 hr after dosing

  2. Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

XenoPort, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 2, 2009
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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