This is an open-label, single centre, parallel group study to evaluate the safety and pharmacokinetics of single oral doses of retigabine XR formulation in healthy adult Japanese subjects. To compare the pharmacokinetic and safety profile, Caucasian subjects are also incorporated. This study is intended to facilitate inclusion of Japanese patients in the global phase III program for retigabine XR formulation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Retigabine
GSK Investigational Site
Kagoshima, Japan
AUC0-∞ of retigabine
Area under the concentration-time curve from pre-dose to last time of quantifiable concentration of retigabine
Time frame: up to 96h post dose
Cmax of retigabine
Maximum observed concentration of retigabine
Time frame: up to 96h post dose
Tmax of retigabine
Time of occurance of Cmax of retigabine
Time frame: up to 96h post dose
t1/2 of retigabine
Terminal phase half-life of retigabine
Time frame: up to 96h post dose
Adverse Events
Number of participants with adverse events as a measure of safety and tolerability (evaluated by the result of Clinical safety laboratory tests, vital signs, 12-lead ECG, telemetry and clinical monitoring/observation
Time frame: up to 96h post dose
AUC0-∞ of NAMR
Area under the concentration-time curve from pre-dose to last time of quantifiable concentration of NAMR
Time frame: up to 96h post dose
Cmax of NAMR
Maximum observed concentration of NAMR
Time frame: up to 96h post dose
Tmax of NAMR
Time of occurance of Cmax of NAMR
Time frame: up to 96h post dose
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t1/2 of NAMR
Terminal phase half-life of NAMR
Time frame: up to 96h post dose
fe
Percent of retigabine and NAMR excreted in urine
Time frame: up to 96h post dose
CLr
Renal clearance of retigabine and NAMR
Time frame: up to 96h post dose