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Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

This study has been completed.
Sponsor:
Information provided by:
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00833391
First received: January 29, 2009
Last updated: May 10, 2013
Last verified: March 2010

January 29, 2009
May 10, 2013
January 2009
March 2009   (final data collection date for primary outcome measure)
gabapentin concentrations in blood [ Time Frame: measured up to 36 hr after dosing ] [ Designated as safety issue: No ]
gabapentin concentrations in blood [ Time Frame: meausred up to 36 hr after dosing ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00833391 on ClinicalTrials.gov Archive Site
  • gabapentin concentrations in urine [ Time Frame: measured up to 36 hr after dosing ] [ Designated as safety issue: No ]
  • Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Pharmacokinetics
  • Healthy Volunteer
Drug: open label
This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.
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.
Intervention: Drug: open label
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833391
110882
Not Provided
Study Director, GSK
XenoPort, Inc.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
XenoPort, Inc.
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP