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Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

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ClinicalTrials.gov Identifier: NCT00833391
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : May 14, 2013
Sponsor:
Information provided by:
XenoPort, Inc.

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

Condition or disease Intervention/treatment Phase
Pharmacokinetics Healthy Volunteer Drug: open label Phase 1

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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open-label, Randomized, Single Dose, Five-period Crossover Study to Evaluate the Relative Bioavailability of Different Formulations of GSK1838262 in Healthy Volunteers.
Study Start Date : January 2009
Primary Completion Date : March 2009
Study Completion Date : March 2009

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.



Primary Outcome Measures :
  1. gabapentin concentrations in blood [ Time Frame: measured up to 36 hr after dosing ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833391


Locations
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
XenoPort, Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00833391     History of Changes
Other Study ID Numbers: 110882
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: March 2010

Keywords provided by XenoPort, Inc.:
healthy volunteer
formulations
bioavailability
pharmacokinetics