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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00833391

Enrollment

Registered

2009-02-02

Start date

2009-01-31

Completion date

2009-03-31

Last updated

2013-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer, Pharmacokinetics

Keywords

healthy volunteer, formulations, bioavailability, pharmacokinetics

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.

Interventions

DRUGopen label

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
gabapentin concentrations in blood	measured up to 36 hr after dosing

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026