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GSK drug
GSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy Volunteers
Ensayo de BIOGEN INC. en Bipolar Disorder (del registro, en inglés).
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 50
- Centros
- 2
- Fin del objetivo primario
- may 2008
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en may 2007.
Qué mide
Part1:AEs for the duration of the study; (duration of the study) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis 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.
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Ficha completa en ClinicalTrials.gov (NCT00488566), actualizada en oct 2017.