Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

XenoPort, Inc.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Pharmacokinetics Healthy Volunteer

Interventions

open labelDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Evansville, Indiana, United States

Outcomes

Primary Outcomes

gabapentin concentrations in blood

Time frame: measured up to 36 hr after dosing

Secondary Outcomes

gabapentin concentrations in urine

Time frame: measured up to 36 hr after dosing

Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.

Time frame: throughout the study

Data from ClinicalTrials.gov

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