A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
22 de enero de 2016 actualizado por: Pfizer
A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.
PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease.
This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
22
Fase
- Fase 2
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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Berlin, Alemania, 10117
- Pfizer Investigational Site
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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
40 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
- Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
- Current smokers, or ex-smokers who have abstained from smoking for at least 6 months
Exclusion Criteria:
- Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
- History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
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 cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
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oral inhaled formulation, single dose
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Comparador activo: comparador activo
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oral inhaled formulation, single dose
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Experimental: PF-03635659
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oral inhaled formulation, single dose, low dose
oral inhaled formulation, single dose, mid dose
oral inhaled formulation, single dose, high dose
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
Periodo de tiempo: Baseline, 24, 24.5 hrs post-dose
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FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose.
Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period.
Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
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Baseline, 24, 24.5 hrs post-dose
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Maximum Observed Plasma Concentration (Cmax)
Periodo de tiempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Dose Normalized Maximum Observed Plasma Concentration
Periodo de tiempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Periodo de tiempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Periodo de tiempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
Periodo de tiempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]
Periodo de tiempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It was obtained from AUC (0 - t) plus AUC (t-∞).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time
Periodo de tiempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It was obtained from AUC (0 - t) plus AUC (t-∞).
AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Plasma Decay Half-Life (t1/2)
Periodo de tiempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peak Forced Expiratory Volume in 1 Second (FEV1)
Periodo de tiempo: Baseline up to 48 hrs post-dose
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FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Peak FEV1 was defined as change from baseline in maximum FEV1.
Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose.
Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.
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Baseline up to 48 hrs post-dose
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Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response
Periodo de tiempo: Baseline up to 24.5 hrs post-dose
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FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5.
Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.
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Baseline up to 24.5 hrs post-dose
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Change From Baseline in Force Vital Capacity (FVC)
Periodo de tiempo: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
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FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible.
Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Change from baseline in FVC was the difference between FVC and baseline FVC.
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Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
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Change From Baseline in Inspiratory Capacity (IC)
Periodo de tiempo: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
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IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally.
Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Change from baseline in IC was the difference between IC and baseline IC.
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Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 2010
Finalización primaria (Actual)
1 de junio de 2010
Finalización del estudio (Actual)
1 de junio de 2010
Fechas de registro del estudio
Enviado por primera vez
15 de diciembre de 2009
Primero enviado que cumplió con los criterios de control de calidad
15 de diciembre de 2009
Publicado por primera vez (Estimar)
16 de diciembre de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de febrero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
22 de enero de 2016
Última verificación
1 de enero de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B0431010
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. .