A Study to Investigate the Appearance and Disappearance of ASP3652 in Blood and Spinal Fluid in Healthy Male Subjects
A Phase I, Open-label Study to Investigate the Safety, Tolerability and Plasma and Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ASP3652 in Healthy Young Caucasian Male Subjects
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Screening takes place between Day -22 to Day -2. Subjects are admitted to the clinical on Day -1 and remain until Day 12.
On Days 5 to 9, subjects receive twice-daily doses of ASP3652, and a single dose on the morning of Day 10. Subjects fast for 10h before the morning dose on Days 5 to 9 and they are served the first standard meal 1h after the morning dose.
A spinal tap is used to collect cerebrospinal fluid (CSF) on Day 1 and Day 10. A plasma sample for PK sample is obtained before first dosing on Day 5. To confirm steady-state concentrations of ASP3652 in plasma, blood samples are obtained before the morning dose on Days 7, 9 and 10, and before the evening dose on Days 5, 7 and 9. On Day 10, a PK profile of ASP3652 in plasma is obtained for up to 48h after the morning dose and for up to 24h in CSF.
Profiles of several enzyme substrates in plasma and seminal fluid (exploratory) are obtained on Day 1 and Day 10 up to 24h in CSF and up to 48h in plasma, before the morning and evening dose on Days 5, 7 and 9 in plasma.
Vital signs, 12-lead electrocardiograms (ECGs), safety laboratory assessments, adverse events (AEs) and concomitant medication are monitored throughout the investigational period until the ESV.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Harrow, Reino Unido, HA1 3UJ
- PAREXEL Early Phase Clinical Unit
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subject is white and of Caucasian origin.
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
- Male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
Exclusion Criteria:
- Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
- History of excessive bleeding or bruising.
- Abnormalities of coagulation screen including platelet count, prothrombin time (PT) and activated partial thromboplastin time (aPTT).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- 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: 1: ASP3652
Multiple doses of ASP3652
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oral
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Pharmacokinetics (PK) of ASP3652 in plasma measured by area under the plasma concentration-time curve in the dosing interval (AUCtau)
Periodo de tiempo: Days 5, 7 and 9, and Days 10 - 12
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Days 5, 7 and 9, and Days 10 - 12
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PK of ASP3652 in plasma measured by maximum observed plasma concentration (Cmax)
Periodo de tiempo: Days 5, 7 and 9, and Days 10 - 12
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Days 5, 7 and 9, and Days 10 - 12
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PK parameter of ASP3652 in cerebrospinal fluid (CSF) measured by area under the plasma concentration-time curve in the dosing interval (AUCtau)
Periodo de tiempo: Days 10 -11
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Days 10 -11
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PK parameter of ASP3652 in cerebrospinal fluid (CSF) measured by maximum observed plasma concentration (Cmax)
Periodo de tiempo: Days 10 -11
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Days 10 -11
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Additional PK of multiple doses of ASP3652 in plasma and cerebrospinal fluid (CSF)
Periodo de tiempo: Plasma: Days 5, 7 and 9, and Days 10 - 12 / CSF: Days 10 -11
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plasma concentration immediately before the next dose (Ctrough), time to attain Cmax (tmax), apparent terminal elimination half-life (t½), volume of terminal phase distribution at steady state (Vz/F), apparent clearance after oral administration at steady state (CL/F) and peak trough ratio (PTR)
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Plasma: Days 5, 7 and 9, and Days 10 - 12 / CSF: Days 10 -11
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Pharmacodynamics (PD) of multiple doses of ASP3652 in plasma and CSF
Periodo de tiempo: Plasma: Days 1-3 and Days 5-12 / CSF: Days 1-2 and Days 10-11
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response immediately prior to dosing (Rtrough), time of the maximum response (tmaxR), maximum response (Rmax), area under the response-time curve from 0 to 12h (AURC0-12h), percentage change in maximum response (Rmax%), percentage change in AURC from 0 to 12h (AUR0-12h%)
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Plasma: Days 1-3 and Days 5-12 / CSF: Days 1-2 and Days 10-11
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Safety and tolerability of multiple doses of ASP3652
Periodo de tiempo: Screening (Day -22 to Day -2) to End-of-Study Visit (7 to 14 days after (early) discharge)
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Screening (Day -22 to Day -2) to End-of-Study Visit (7 to 14 days after (early) discharge)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 3652-CL-0048
- 2011-004226-97 (Número EudraCT)
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