Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

XenoPort

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer; Pharmacokinetics

Treatments: Drug: open label

Study type: Interventional

Funder types: Industry

Identifiers

NCT00833391

110882

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

16 participants in 1 patient group

GSK1838262 arm

Experimental group

Description:

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.

Treatment:

Drug: open label