- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01299558
Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects
9 de junio de 2017 actualizado por: GlaxoSmithKline
An Open-label, Non-randomised, Three-way Crossover, Single Dose Study to Determine the Absolute Bioavailability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder, in Healthy Subjects
This study is being done to look at the absolute bioavailability of fluticasone furoate and GW642444 inhalation powder when administered in healthy subjects.
Bioavailability is determined by measuring the amount of the dose of inhaled medication that reaches the circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared to the medication administered intravenously (where bioavailability is 100%).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Fluticasone furoate (FF), a novel glucocorticoid, and GW642444, a potent, inhaled longacting, beta2-receptor agonist (LABA), are currently under development in combination for use as a once-daily, inhaled treatment for asthma and chronic obstructive pulmonary disease (COPD).
FF is also being developed as a stand-alone product for asthma and GW642444 is also being developed as a stand-alone product and in combination with a novel, long-acting muscarinic antagonist for the treatment of COPD.
This study is being performed to determine the absolute bioavailability of both FF and GW642444 when delivered in combination from the novel dry powder inhaler.
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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New South Wales
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Randwick, New South Wales, Australia, 2031
- GSK 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
18 años a 64 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy male or female between 18 and 64 years of age inclusive
- Body mass index (BMI) within the range 18.5-29 0 kg/m2 (inclusive)
- Subjects who are current non-smokers
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block, based on a single ECG value, or an average from three ECGs obtained over a brief recording period
- No significant abnormality on the Holter ECG at screening
- FEV1 ≥ 85% predicted at screening.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Subjects who are able to use the inhalation device satisfactorily
Exclusion Criteria:
- As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg
- Any history of breathing problems in adult life
- Pregnant or lactating females
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit
- Subjects with recent history (within 6 months) of pneumonia
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
- Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate)
- History of milk protein allergy
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety
- The subject has taken oral corticosteroids less than 8 weeks before the screening visit
- The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit
- History of alcohol/drug abuse or dependence within 12 months of the study
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- The subject has tested positive for HIV antibodies
- A positive pre-study urine drug screen or when randomly tested during the study
- Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit.
- Positive urine cotinine test at screening
- Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
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: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Treatment period 1
Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder given once daily in the morning on Day 1 of Treatment period 1
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Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning
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Otro: Treatment Period 2
Single IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2
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Single IV dose of FF (250mcg)
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Otro: Treatment Period 3
Single IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3
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Single IV dose of GW642444 (55mcg)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Absolute bioavailability of FF and GW642444 following single dose of FF/GW642444M Inhalation Powder; determined by measuring the amount of the dose of inhaled medication that reaches the circulation compared to the medication administered intravenously
Periodo de tiempo: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax, and MRT for all treatments. In addition, volume of distribution (V) and plasma clearance (CL) for intravenous administrations and mean absorption time (MAT) for inhaled treatments
Periodo de tiempo: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Number of Participants with clinically significant changes to Vital Signs as a measure of Safety and Tolerability
Periodo de tiempo: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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Number of Participants with clinically significant changes to 12-lead ECG Tests as a measure of Safety and Tolerability
Periodo de tiempo: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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Number of Participants with clinically significant changes to Clinical Laboratory Tests as a measure of Safety and Tolerability
Periodo de tiempo: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Periodo de tiempo: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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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 (Actual)
17 de mayo de 2010
Finalización primaria (Actual)
15 de julio de 2010
Finalización del estudio (Actual)
15 de julio de 2010
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2010
Primero enviado que cumplió con los criterios de control de calidad
17 de febrero de 2011
Publicado por primera vez (Estimar)
18 de febrero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 102934
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Datos del estudio/Documentos
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Plan de Análisis Estadístico
Identificador de información: 102934Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: 102934Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: 102934Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: 102934Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: 102934Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Informe de estudio clínico
Identificador de información: 102934Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: 102934Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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. .
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