Succinate Salt Version of GSK961081 for Healthy Volunteers
28 de septiembre de 2021 actualizado por: Theravance Biopharma
A Randomised, Double-blind, Dose Escalating Study in Healthy Volunteers to Assess the Safety, Tolerability, Extra Pulmonary Pharmacodynamics and Pharmacokinetics of Single Doses of GSK961081 (Succinate Salt)
Salt Bridging study for GSK961081
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
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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London, Reino Unido, NW10 7NS
- 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 50 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- Healthy adult males or female aged between 18 and 50 years.
- Body mass index within the range 19-29.9 kilograms/metre2
- Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7
- Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.
Exclusion criteria:
- Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
- History of respiratory disease
- Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec
- Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
- Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
- Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months
- Infected with the Hepatitis B, Hepatitis C, or HIV virus
- Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
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
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Sequence 1
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
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GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
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|
Experimental: Sequence 2
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
Experimental: Sequence 3
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
Experimental: Sequence 4
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
Experimental: Sequence 5
In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
Experimental: Sequence 6
In session 1, subjects will receive placebo followed by 900 micrograms of GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
Experimental: Sequence 7
In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
Experimental: Sequence 8
In session 1, subjects will receive placebo followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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FEV1 at intervals
Periodo de tiempo: during the 10 week study
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during the 10 week study
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Cardiac monitoring at intervals
Periodo de tiempo: during the 10 week study
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during the 10 week study
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Plasma concentrations of GSK961081 at intervals
Periodo de tiempo: during the 10 week study
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during the 10 week study
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PK parameters at intervals
Periodo de tiempo: during the 10week study
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during the 10week study
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
29 de noviembre de 2007
Finalización primaria (Actual)
8 de enero de 2008
Finalización del estudio (Actual)
8 de enero de 2008
Fechas de registro del estudio
Enviado por primera vez
26 de octubre de 2007
Primero enviado que cumplió con los criterios de control de calidad
26 de octubre de 2007
Publicado por primera vez (Estimar)
29 de octubre de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
28 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MAB108115
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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Conjunto de datos de participantes individuales
Identificador de información: MAB108115Comentarios 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: MAB108115Comentarios 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: MAB108115Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: MAB108115Comentarios 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: MAB108115Comentarios 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: MAB108115Comentarios 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: MAB108115Comentarios 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. .
Ensayos clínicos sobre GSK961081
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Theravance BiopharmaGlaxoSmithKline; Hammersmith Medicines ResearchTerminadoEnfermedad Pulmonar Obstructiva CrónicaReino Unido
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GlaxoSmithKlineTerminadoEnfermedad Pulmonar Obstructiva CrónicaAustralia
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GlaxoSmithKlineTerminadoEnfermedad Pulmonar Obstructiva CrónicaAlemania, Rumania, Ucrania, Estonia, Federación Rusa, Sudáfrica, Suecia, Países Bajos, Eslovaquia