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A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects

21 de outubro de 2015 atualizado por: Galapagos NV

A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).

Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated.

A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

24

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

  • Bélgica
      • Antwerp, Bélgica
        • SGS LSS Clinical Pharmacology Unit Antwerp

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 50 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Macho

Descrição

Inclusion Criteria:

  • healthy male, age 18-50 years
  • BMI between 18-30 kg/m2

Exclusion Criteria:

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

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 de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Midazolam and 500 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.
Medicamento: GLPG1837 500 mg
Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.
Medicamento: Midazolam
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Experimental: Midazolam and 1000 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.
Medicamento: Midazolam
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Medicamento: GLPG1837 1000 mg
Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Prazo: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects
Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Prazo: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837
Prazo: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects
Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Prazo: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Prazo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
Number of adverse events
Prazo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of the number of adverse events reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature
Prazo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in 12-lead ECG measures
Prazo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in 12-ECG measures reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in physical exam measures
Prazo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in physical examination reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in blood safety lab parameters
Prazo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in blood safety lab parameters reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
Changes in urine safety lab parameters
Prazo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in urine safety lab parameters reported
Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Prazo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Prazo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Prazo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
The metabolite to GLPG1837 ratios in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Prazo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
To characterize the metabolite to GLPG1837 ratios in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Galapagos NV

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 setembro de 2015

Conclusão Primária (Real)

1 de outubro de 2015

Conclusão do estudo (Real)

1 de outubro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

23 de setembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de setembro de 2015

Primeira postagem (Estimativa)

29 de setembro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

23 de outubro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de outubro de 2015

Última verificação

1 de outubro de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GLPG1837-CL-102
  • 2015-002517-29 (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 .

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