Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

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

Detailed Description
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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.

Official Title
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An Open-label, Randomized, Single Dose, Five-period Crossover Study to Evaluate the Relative Bioavailability of Different Formulations of GSK1838262 in Healthy Volunteers.

Conditions
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Pharmacokinetics, Healthy Volunteer

Intervention / Treatment
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* Drug: open label


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK1838262 arm<br>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. | Drug: open label<br>* This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gabapentin concentrations in blood |  | measured up to 36 hr after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteer, formulations, bioavailability, pharmacokinetics