A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
18 de julho de 2017 atualizado por: GlaxoSmithKline
Double Blind, Double-dummy, Randomised, Placebo Controlled Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
The purpose of this study is to investigate the effect of drug A on its own and when it is given in combination with drug B on markers of brain activity. The study will
- Assess the effects of drug A and drug B on muscle movement after brain stimulation;
- Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination;
- Examine the safety of drug A and drug B when given together.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
12
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Niedersachsen
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Goettingen, Niedersachsen, Alemanha, 37075
- GSK Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- Healthy subject
- Male aged 18-65
- Greater than 50kg weight
- BMI 19-29.9 kg/m2
Exclusion Criteria:
- Positive drug/alcohol screen
- Positive HIV antibody
- History of drug dependence
- History of neurological disease
- Pacemaker
- Smoker
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Treatment sequence A
Subjects on sequence A will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence B
Subjects on sequence B will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence C
Subjects on sequence C will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence D
Subjects on sequence D will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence E
Subjects on sequence E will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence F
Subjects on sequence F will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence G
Subjects on sequence G will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence H
Subjects on sequence H will receive single dose of placebo part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence I
Subjects on sequence I will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence J
Subjects on sequence J will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence K
Subjects on sequence K will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence L
Subjects on sequence L will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence M
Subjects on sequence M will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence N
Subjects on sequence N will receive single dose of vofopitant 10 milligrams capsule in part 1, placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence O
Subjects on sequence O will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence P
Subjects on sequence P will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence Q
Subjects on sequence Q will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence R
Subjects on sequence R will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence S
Subjects on sequence S will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
|
Experimental: Treatment sequence T
Subjects on sequence T will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2.
|
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally.
It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Effect of the study treatments on Resting Motor Thresholds (rMT)
Prazo: Within 24 hours
|
Within 24 hours
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
The safety and tolerability of the combination of study treatments.
Prazo: Within 24 hours
|
Within 24 hours
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de maio de 2009
Conclusão Primária (Real)
10 de junho de 2010
Conclusão do estudo (Real)
10 de junho de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
7 de maio de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2009
Primeira postagem (Estimativa)
25 de maio de 2009
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de julho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de julho de 2017
Última verificação
1 de julho de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Transtornos Bipolares e Relacionados
- Transtorno bipolar
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Depressores do Sistema Nervoso Central
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Antieméticos
- Agentes gastrointestinais
- Antipsicóticos
- Agentes Tranquilizantes
- Drogas Psicotrópicas
- Moduladores de transporte de membrana
- Anticonvulsivantes
- Bloqueadores dos Canais de Sódio
- Hormônios e Agentes Reguladores de Cálcio
- Bloqueadores dos Canais de Cálcio
- Antagonistas do Receptor da Neuroquinina-1
- Lamotrigina
- Vofopitanto
Outros números de identificação do estudo
- 112676
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Dados/documentos do estudo
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Formulário de Consentimento Informado
Identificador de informação: 112676Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Relatório de Estudo Clínico
Identificador de informação: 112676Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulário de Relato de Caso Anotado
Identificador de informação: 112676Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocolo de estudo
Identificador de informação: 112676Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Plano de Análise Estatística
Identificador de informação: 112676Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Especificação do conjunto de dados
Identificador de informação: 112676Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Conjunto de dados de participantes individuais
Identificador de informação: 112676Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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