Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
4 de mayo de 2012 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
16
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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Zuidlaren, Países Bajos
- 001
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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 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
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
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
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: 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
Otros nombres:
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Otro: 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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Lacosamide trough plasma concentration (Ctrough)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Single measurement on Day 1
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Single measurement on Day 1
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VKORC1 genotype
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: UCB Clinical Trial Call Center, 1 877 822 9493
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 enero de 2012
Finalización primaria (Actual)
1 de marzo de 2012
Finalización del estudio (Actual)
1 de marzo de 2012
Fechas de registro del estudio
Enviado por primera vez
31 de enero de 2012
Primero enviado que cumplió con los criterios de control de calidad
2 de febrero de 2012
Publicado por primera vez (Estimar)
3 de febrero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de mayo de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
4 de mayo de 2012
Última verificación
1 de mayo de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EP0013
- 2011-004911-21 (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. .