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This study is being conducted to provide initial safety and tolerability data as well as to provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered in healthy male adults
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW856553 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| PK blood draws at days 14 and 28 | days 14 and 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary pharmacokinetic endpoints of interest are AUC(0-Ï„) and Cmax for rosuvastatin | days 14, 15, 28 | |
| The secondary pharmacokinetic endpoints of interest are Tmax and t1/2 for rosuvastatin | days 14, 15, 28 |
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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 | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C543534 | 6-(5-((cyclopropylamino)carbonyl)-3-fluoro-2-methylphenyl)-N-(2,2-dimethylprpyl)-3-pyridinecarboxamide |
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| Measurement of alanine aminotransferase (ALT) and maximum change from baseline in ALT in all subjects | days -1, 13, 14, 16, 18, 20, 22, 24, 26, 28, follow up |
| Clinical safety data from spontaneous adverse event reporting, 12-lead ECG recording, vital sign measurement, nursing/physician observation and safety laboratory examination. | days -1, 13, 14, 16, 22, 26, 28, follow up |
| Analysis of LPS induction of IL-1b, IL-6, IL-8 and TNFa, as well as additional biomarkers, as data permit. | day 1, 14, 21, 28 |