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To determine safety, tolerability and Pharmacokinetics of GSK1247303
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1247303 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| safety (adverse events, laboratory, ECG and vital signs assessments) and plasma pharmacokinetics of single and repeat doses of GSK1247303 |
| Measure | Description | Time Frame |
|---|---|---|
| Day 10 GSK1247303 AUC(0-t) compared to AUC(0-12) and/or AUC(0-24) on Day 1 to estimate accumulation ratio (R) and GSK1247303 AUC(0-t) on Day 10 compared to AUC on Day 1 to evaluate time invariance following repeat administration of GSK1247303. | day 1 and day 10 | |
| Pre-morning dose concentrations (Ct) on Day 2 through 10 to assess the achievement of steady state of GSK1247303 following repeat administration. |
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Inclusion Criteria:
Exclusion Criteria:
Note: 1 drink is equivalent to 12 g alcohol = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Overland Park | Kansas | 66211 | United States |
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| Day 2 through 10 |
| GSK1247303 PK parameters: AUC(0-t), AUC(0-t), Cmax, and C12 and/or C24 following single dose administration and AUC(0-t), Ct, Cmin, and Cmax following repeat administration at different doses for the assessment of dose proportionality. |