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The purpose of this study is to compare the effects of fasting and fed conditions with repeat doses of GSK256073F in HVT subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fixed sequence | Other | fixed sequence (14 days fasted followed by 14 days either high fat or standard meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK256073 | Drug | GSK256073 100 mg study drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. AUC0-inf, Cmax, and Ctrough (Ct) under fasting conditions | throughout study | |
| 2. AUC0-inf, Cmax, and Ctrough (Ct) under fed conditions | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Safety and tolerability will be assessed by vital signs, ECGs, clinical laboratory data, spontaneous AE reporting, nursing/physician observation and assessment of flushing via a visual analog scale | throughout the study | |
| 2. Tmax, t½ (if data permits), Ae (amount excreted in the urine), CLr (renal clearance), Cmax, ss, and Cτ following repeat dose |
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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 | Baltimore | Maryland | 21225 | United States |
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| ID | Term |
|---|---|
| C000604188 | 8-chloro-3-pentyl-1H-purine-2,6(3H,7H)-dione |
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| throughout the study |
| 3. Pharmacodynamic endpoints may include TC, NEFA, HDL, LDL, TG, ApoA1, ApoA2, ApoB, Lp(a), CETP, adiponectin, liposcience (particle sizing) or other markers of dyslipidemia on Days 1, 14, 21, and 28, as data permit. | throughout the study |