GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models. This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy male or female subjects. In addition, the effect of food on the pharmacokinetics of GSK1014802 will be investigated.
This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now been acquired by Biogen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
51
Tablets to match GSK1014802
Sodium channel blocker
GSK Investigational Site
London, United Kingdom
Safety and tolerability will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters.
Time frame: 14-28 days
Blood concentrations of GSK1014802 following a single oral dose of GSK1014802.
Time frame: 1 day
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily or twice daily and their relationship with the GSK1014802 exposure after a single dose.
Time frame: 14-28 days
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily with or without food.
Time frame: 14-28 days
Bond-Lader VAS scale
Time frame: 14-28 days
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