Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

Healthy Volunteer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833391
• Other study ID #: 110882
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2009
• Last updated: May 10, 2013
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: March 2010
• Source: XenoPort, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer
• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
XenoPort, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gabapentin concentrations in blood		measured up to 36 hr after dosing	No
Secondary	gabapentin concentrations in urine		measured up to 36 hr after dosing	No
Secondary	Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.		throughout the study	No