Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The rationale of this study is to assess whether or not food affects the absorption of GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or not this drug should be given at a certain time relative to the consumption of food.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB | Experimental | Subjects will be randomized to sequence AB, where A represents fasted state and B represents fed state. Subjects will be administered a single oral dose of GW273225 50 milligrams (mg) in the fasted state in dosing period 1. The subjects will receive a single oral dose of GW273225 50 mg immediately after a high fat breakfast in dosing period 2. There will be at least 21 days between doses for the fasted and fed treatment phases of the study. |
|
| Sequence BA | Experimental | Subjects will be randomized to sequence BA, where A represents fasted state and B represents fed state. Subjects will be orally administered a single dose of GW273225 50 mg immediately after a high fat breakfast in dosing period 1. The subjects will receive a single oral dose of GW273225 50 mg in the fasted state in dosing period 2. There will be at least 21 days between doses for the fed and fasted treatment phases of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW273225 | Drug | GW273225 will be available as white tablets containing 25 mg GW273225.The study drug will be taken with 240 milliliters of water at room temperature. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability and maximal concentration of the drug measured between 0 hours and 216 hours post dose. | measured between 0 hours and 216 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximal concentration measured between 0-216h post dose. Clinically relevant changes from baseline in clinical laboratory parameters (48 hours post dose), ECGs (0-48h post dose) and vital signs (0-48 hours post dose and any AEs during the study. | Time to maximal concentration measured between 0-216h post dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | Cambridgeshire | CB3 7TR | United Kingdom |
Not provided
| Label | URL |
|---|---|
| Results for study 109169 can be found on the GSK Clinical Study Register. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided