Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

Phase 1

Completed

• Conditions: Pharmacokinetics; Healthy Volunteer
• Interventions: Drug: open label

• Registration Number: NCT00833391
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-02-02
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-03
• Last Update Submitted: 2013-05-10
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GSK1838262 arm	open label	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.

Primary Outcome Measures

Name	Time	Method
gabapentin concentrations in blood	measured up to 36 hr after dosing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Evansville, Indiana, United States