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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
  Purpose

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


Condition Intervention Phase
Pharmacokinetics
Healthy Volunteer
Drug: open label
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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.

Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:
  • gabapentin concentrations in blood [ Time Frame: measured up to 36 hr after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00833391     History of Changes
Other Study ID Numbers: 110882
Study First Received: January 29, 2009
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014