Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
4 de maio de 2012 atualizado por: UCB Pharma
Single-center, Open-label, Randomized 2-way Crossover Study of the Effect of Lacosamide 200 mg Twice Daily on the Single-dose Pharmacokinetics and Pharmacodynamics of Warfarin (25 mg) in Healthy Male Volunteers
The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy male volunteers.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
16
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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Zuidlaren, Holanda
- 001
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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 55 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- Healthy male volunteers 18-55 years of age
- BMI 18.0-30.0 kg/m2 and weight at least 50 kg
- Tympanic body temperature 35.0-37.5°C (95 and 99.5°F) inclusive
Exclusion Criteria:
- Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
- Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- Volunteer is taking Warfarin or Non Steroidal Anti-Inflammatory Drug (NSAID)
- Volunteer has history of suicide attempt
- Volunteer has history of coagulation abnormalities, occult blood in stool, gastrointestinal ulcer, surgery within 6 months
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
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: Single dose of Warfarin on day 3
Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID
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Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
Outros nomes:
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Outro: Single dose of Warfarin
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Strength: 5 mg, Form: Tablet, Frequency: 1 single dose in each period In total, during the two periods, each healthy volunteer will receive 2 single doses 3 weeks apart. Duration: single dose
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Prazo: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Area under the Warfarin plasma concentration versus time curve from time 0 to the last quantifiable level, AUC0-t(Warfarin)
Prazo: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Maximum Warfarin plasma concentration (Cmax)
Prazo: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Maximum prothrombin time (PTmax)
Prazo: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Warfarin area under the prothrombin time (PT) versus time curve (PTAUC)
Prazo: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
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Warfarin maximum international normalized ratio (INRmax)
Prazo: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Warfarin area under the International Normalized Ratio (INR) versus time curve (INRAUC)
Prazo: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Lacosamide trough plasma concentration (Ctrough)
Prazo: Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
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Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
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Time of maximum Warfarin plasma concentration (Tmax)
Prazo: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Terminal half-life of Warfarin (T ½)
Prazo: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Apparent total body clearance of Warfarin (CL /F)
Prazo: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Apparent volume of distribution of Warfarin (V /F)
Prazo: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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First order terminal elimination rate constant of Warfarin
Prazo: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
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CYP2C9 genotype
Prazo: Single measurement on Day 1
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Single measurement on Day 1
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VKORC1 genotype
Prazo: Single measurement on Day 1
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Single measurement on Day 1
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Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) during the duration of the study
Prazo: Duration of study is approximately 32 days
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Duration of study is approximately 32 days
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Change from Baseline in Pulse Rate at 4 h post dose
Prazo: From pre dose to 4 h post dose Warfarin administration in each treatment period
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40-90 bpm
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From pre dose to 4 h post dose Warfarin administration in each treatment period
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Change from Baseline in Pulse Rate at 12 h post dose
Prazo: From pre dose to 12 h post dose Warfarin administration in each treatment period
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40-90 bpm
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From pre dose to 12 h post dose Warfarin administration in each treatment period
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Change from Baseline in Pulse Rate at 24 h post dose
Prazo: From pre dose to 24 h post dose Warfarin administration in each treatment period
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40-90 bpm
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From pre dose to 24 h post dose Warfarin administration in each treatment period
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Change from Baseline in Pulse Rate at 4 h post dose
Prazo: From pre dose to 4 h post dose Lacosamide (LCM) administration
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40-90 bpm
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From pre dose to 4 h post dose Lacosamide (LCM) administration
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Change from Baseline in Pulse Rate at 12 h post dose
Prazo: From pre dose to 12 h post dose LCM administration
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40-90 bpm
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From pre dose to 12 h post dose LCM administration
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Change from Baseline in Systolic Blood Pressure at 4 h post dose
Prazo: From pre dose to 4 h post dose Warfarin administration in each treatment period
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From pre dose to 4 h post dose Warfarin administration in each treatment period
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Change from Baseline in Systolic Blood Pressure at 12 h post dose
Prazo: From pre dose to 12 h post dose Warfarin administration in each treatment period
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From pre dose to 12 h post dose Warfarin administration in each treatment period
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Change from Baseline in Systolic Blood Pressure at 24 h post dose
Prazo: From pre dose to 24 h post dose Warfarin administration in each treatment period
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From pre dose to 24 h post dose Warfarin administration in each treatment period
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Change from Baseline in Systolic Blood Pressure at 4 h post dose
Prazo: From pre dose to 4 h post dose LCM administration
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From pre dose to 4 h post dose LCM administration
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Change from Baseline in Systolic Blood Pressure at 12 h post dose
Prazo: From pre dose to 12 h post dose LCM administration
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40-90 bpm
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From pre dose to 12 h post dose LCM administration
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Change from Baseline in Diastolic Blood Pressure at 4 h post dose
Prazo: From pre dose to 4 h post dose Warfarin administration in each treatment period
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From pre dose to 4 h post dose Warfarin administration in each treatment period
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Change from Baseline in Diastolic Blood Pressure at 12 h post dose
Prazo: From pre dose to 12 h post dose Warfarin administration in each treatment period
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From pre dose to 12 h post dose Warfarin administration in each treatment period
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Change from Baseline in Diastolic Blood Pressure at 24 h post dose
Prazo: From pre dose to 24 h post dose Warfarin administration in each treatment period
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From pre dose to 24 h post dose Warfarin administration in each treatment period
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Change from Baseline in Diastolic Blood Pressure at 4 h post dose
Prazo: From pre dose to 4 h post dose LCM administration
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From pre dose to 4 h post dose LCM administration
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Change from Baseline in Diastolic Blood Pressure at 12 h post dose
Prazo: From pre dose to 12 h post dose LCM administration
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40-90 bpm
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From pre dose to 12 h post dose LCM administration
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Change from Baseline in Body Temperature at 4h post dose
Prazo: From pre dose to 4 h post dose Warfarin administration in each treatment period
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From pre dose to 4 h post dose Warfarin administration in each treatment period
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Change from Baseline in Body Temperature at 12 h post dose
Prazo: From pre dose to 12 h post dose Warfarin administration in each treatment period
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From pre dose to 12 h post dose Warfarin administration in each treatment period
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Change from Baseline in Body Temperature at 24 h post dose
Prazo: From pre dose to 24 h post dose Warfarin administration in each treatment period
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From pre dose to 24 h post dose Warfarin administration in each treatment period
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Change from Baseline in Body Temperature at 4 h post dose
Prazo: From pre dose to 4 h post dose LCM administration
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From pre dose to 4 h post dose LCM administration
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Change from Baseline in Body Temperature at 12 h post dose
Prazo: From pre dose to 12 h post dose LCM administration
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40-90 bpm
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From pre dose to 12 h post dose LCM administration
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: UCB Clinical Trial Call Center, 1 877 822 9493
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
1 de janeiro de 2012
Conclusão Primária (Real)
1 de março de 2012
Conclusão do estudo (Real)
1 de março de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
31 de janeiro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de fevereiro de 2012
Primeira postagem (Estimativa)
3 de fevereiro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
7 de maio de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de maio de 2012
Última verificação
1 de maio de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EP0013
- 2011-004911-21 (Número EudraCT)
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 .