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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1838262 arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open label | Drug | This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262. |
|
| Measure | Description | Time Frame |
|---|---|---|
| gabapentin concentrations in blood | measured up to 36 hr after dosing |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Evansville | Indiana | 47710 | United States |
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