This is a single-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2374697 in healthy volunteers. The study will enrol approximately 72 subjects at one clinical study center in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
GSK2376497 Active Comparator
0.9% sodium chloride Placebo Comparator
GSK Investigational Site
Minneapolis, Minnesota, United States
Number of subjects with adverse events after ascending single or titrated mulitple subcutaneous doses of GSK2374697
Adverse events, laboratory parameters, ECGs, and vital signs
Time frame: up to 70 days post dose
pharmacokinetic parameters of GSK2374697, after ascending single or titrated multiple subcutaneous doses, in healthy subjects
Pharmacokinetics parameters: AUCs, Cmax, tmax, elimination half-life (t½), lag time (tlag), apparent clearance (CL/F) and apparent volume of distribution (V/F), area under the plasma drug concentration versus time curve on Days 1 through end of study (up to 70 Days)
Time frame: pre-dose, then 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 66 hours after dose (this schedule is q6h through Day 3, up to just prior to Day 4). In addition, sampling continues out through Day 70, on specific days, q12h.
pharmacodynamic effects of GSK2374697 in healthy subjects after meal challenge
Fasting, 2h, and Cmax parameters on Day -1 and approximately Day 6 (or Day 16)
Time frame: On 2 days
dose proportionality of GSK2374697
Pharmacokinetics parameters based on single and/or titrated multiple subcutaneous doses of GSK2374697
Time frame: up to 70 days post dose
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