The purpose of this study is to compare the effects of fasting and fed conditions with repeat doses of GSK256073F in HVT subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
GSK256073 100 mg study drug
GSK Investigational Site
Baltimore, Maryland, United States
1. AUC0-inf, Cmax, and Ctrough (Ct) under fasting conditions
Time frame: throughout study
2. AUC0-inf, Cmax, and Ctrough (Ct) under fed conditions
Time frame: throughout the study
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
Time frame: 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
Time frame: 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.
Time frame: throughout the study
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