GSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy Volunteers
Status:
Completed
Trial end date:
2008-05-31
Target enrollment:
Participant gender:
Summary
This is a First Time in Human Study to assess the safety, tolerability, pharmacokinetics and
resting motor threshold (rMT) of single doses of GSK drug in healthy volunteers.This will be
a 2 part and 2 centre study.Part 1 will be a double-blind, randomized, placebo-controlled,
single oral dose, dose-rising, cross-over study in healthy male and female (of non-child
bearing potential) volunteers.Subjects will be randomized into cohorts of 10 subjects and
cohorts will be recruited until the pre-defined safety or PK stopping limits are reached.Each
subject will receive placebo and no more than 4 ascending doses of GSK drug in a randomized
sequence on 5 separate study occasions.Each dosing session will take place over 2 days and
there will be at least one subject on placebo on each day. There will be only one subject on
any new active dose during the first day.Part 2 will be a randomised, double-blind,
double-dummy, placebo-controlled, cross-over study to investigate the effect of single doses
of GSK drug and lamotrigine on resting motor threshold in healthy male subjects. Subjects
will attend the unit a maximum of 4 separate occasions.During each session subjects will
receive up to 4 TMS measurements and single doses of either GSK drug, lamotrigine or placebo,
in a randomised manner.Up to two doses of GSK drug will be investigated.