NCT00488566

GSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy Volunteers

Double Blind, Randomised, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of GSK Drug and the Effect of Single Doses of GSK Drug or Lamotrigine on Resting Motor Threshold in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	GSK drug	GSK drug
OTHER	Placebo	Placebo
OTHER	Lamictal	Positive control

Timeline

• Start date: 2007-05-31
• Primary completion: 2008-05-31
• Completion: 2008-05-31
• First posted: 2007-06-20
• Last updated: 2017-10-26

Locations

2 sites across 1 country: United Kingdom