A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects
21 de octubre de 2015 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
24
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Antwerp, Bélgica
- SGS LSS Clinical Pharmacology Unit Antwerp
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
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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.
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Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Periodo de tiempo: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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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
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Periodo de tiempo: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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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
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837
Periodo de tiempo: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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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
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
Periodo de tiempo: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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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
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Periodo de tiempo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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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
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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Number of adverse events
Periodo de tiempo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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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
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature
Periodo de tiempo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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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
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in 12-lead ECG measures
Periodo de tiempo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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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
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in physical exam measures
Periodo de tiempo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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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
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in blood safety lab parameters
Periodo de tiempo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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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
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in urine safety lab parameters
Periodo de tiempo: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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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
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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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)
Periodo de tiempo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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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
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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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)
Periodo de tiempo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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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
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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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)
Periodo de tiempo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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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
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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The metabolite to GLPG1837 ratios in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
Periodo de tiempo: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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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
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2015
Finalización primaria (Actual)
1 de octubre de 2015
Finalización del estudio (Actual)
1 de octubre de 2015
Fechas de registro del estudio
Enviado por primera vez
23 de septiembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
27 de septiembre de 2015
Publicado por primera vez (Estimar)
29 de septiembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
23 de octubre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2015
Última verificación
1 de octubre de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Anestésicos Intravenosos
- Anestésicos Generales
- Anestésicos
- Agentes tranquilizantes
- Drogas psicotropicas
- Hipnóticos y sedantes
- Adyuvantes, Anestesia
- Agentes contra la ansiedad
- Moduladores GABA
- Agentes GABA
- Midazolam
Otros números de identificación del estudio
- GLPG1837-CL-102
- 2015-002517-29 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .