- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00866515
Drug Interaction Study to Investigate Co-administration of GW642444M With Ketoconazole
13 de julio de 2017 actualizado por: GlaxoSmithKline
A Double-blind, Placebo-controlled, Randomised, 2-way Crossover Drug Interaction Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects Following Co-administration of GW642444M With Ketoconazole
This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects.
There will be two treatment periods each consisting of 7 days.
During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects.
There will be two treatment periods each consisting of 7 days.
During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
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 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the discretion of the Investigator only if the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until after the final follow-up visit has been completed.
- Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
- Demonstrated ability to use the inhaler device in a satisfactory and repeatable manner
- Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of ≤ 10 pack years.
- No significant abnormality on 12-lead ECG at screening, including the following requirements:
- Ventricular rate ≥ 40 beats per minute
- PR interval ≥ 120 and ≤ 210 msec
- Q waves < 30 msec (up to 50 msec permitted in lead III only)
- QRS interval to be ≥ 60 msec and ≤ 120 msec
- QTc interval must be < 450 msec (QTcB or QTcF; machine or manual reading) based on an average from three ECGs obtained over a brief recording period
- FEV1 ≥ 80% predicted and a FEV1 / FVC ratio ≥ 0.7 at screening
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
- As a result of medical interview, physical examination or screening investigations, the principle investigator or delegate physician deems the subject unsuitable for the study.
- Systolic blood pressure which is outside the range 90 to 140 mmHg, diastolic blood pressure outside the range 50 to 90 mmHg or heart rate outside the range 40 to 90 bpm.
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
- The subject has any history of breathing problems in adult life (i.e. history of asthmatic symptomatology).
- A clinically significant abnormality on standard pulmonary function testing, or any other finding that would prevent satisfactory administration of the inhaled study medication.
- Any contraindication to the administration of ketoconazole, as described in the current [NIZORAL Product Information, Janssen-Cilag Pty Limited, 2008].
- History of sensitivity to any of the study medications, or components thereof (including milk protein) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Currently taking regular (or a course of) medication whether prescribed or not, with the exception of those permitted medications listed in Section 8.1 and Section 9.1.
- 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.
- History of regular alcohol consumption within 6 months of the study defined as:
- An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~250 mL) of beer, 1 glass (100 mL) of wine or 1 measure (30 mL) of spirits.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- The subject has donated a unit of blood within the previous 16 weeks or intends to donate within 16 weeks after completing the study.
- 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.
- The subject has a positive pre-study urine drug screen/ alcohol breath test. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subjects who have a screening haemoglobin value < 110 mg/L.
- Pregnant (as determined by positive (serum or urine) hCG test at screening or prior to dosing) or lactating females.
- Subject is mentally or legally incapacitated.
- CO breath monitoring indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
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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Experimental: Active
Ketoconazole 400mg OD days 1-6
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Ketoconazole 400mg OD days 1-6, GW642444M 25ug single dose on D5
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Comparador de placebos: Placebo
Placebo OD for 1 to 6 days
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Placebo to match D1-6 + GW642444M 25ug single dose on D5
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Supine heart rate and blood potassium levels
Periodo de tiempo: Day 5
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Day 5
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Plasma GW642444M concentrations
Periodo de tiempo: Day 5
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Day 5
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Reported Adverse Events
Periodo de tiempo: treatment periods
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treatment periods
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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)
22 de diciembre de 2008
Finalización primaria (Actual)
27 de marzo de 2009
Finalización del estudio (Actual)
27 de marzo de 2009
Fechas de registro del estudio
Enviado por primera vez
22 de enero de 2009
Primero enviado que cumplió con los criterios de control de calidad
19 de marzo de 2009
Publicado por primera vez (Estimar)
20 de marzo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
13 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades Pulmonares Obstructivas
- Enfermedad Pulmonar Obstructiva Crónica
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de enzimas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Inhibidores del citocromo P-450 CYP3A
- Inhibidores de enzimas del citocromo P-450
- Antagonistas de hormonas
- Agentes antifúngicos
- Inhibidores de la síntesis de esteroides
- Inhibidores de la 14-alfa desmetilasa
- Ketoconazol
Otros números de identificación del estudio
- 112205
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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Formulario de consentimiento informado
Identificador de información: 112205Comentarios 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: 112205Comentarios 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: 112205Comentarios 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: 112205Comentarios 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: 112205Comentarios 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: 112205Comentarios 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: 112205Comentarios 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 Ketoconazole + GW642444M
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GlaxoSmithKlineTerminadoAsmaEstados Unidos, Argentina, Polonia, Federación Rusa, Bélgica, Canadá, Chile, Francia, Alemania, Corea, república de, Países Bajos, Perú, Filipinas, Sudáfrica, Suecia, Tailandia
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GlaxoSmithKlineTerminadoEnfermedad Pulmonar Obstructiva CrónicaReino Unido
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GlaxoSmithKlineTerminadoEnfermedad Pulmonar Obstructiva CrónicaAustralia, Nueva Zelanda
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GlaxoSmithKlineTerminadoEnfermedad Pulmonar Obstructiva CrónicaAlemania
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GlaxoSmithKlineTerminado
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GlaxoSmithKlineTerminado
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GlaxoSmithKlineTerminadoEnfermedad Pulmonar Obstructiva CrónicaReino Unido
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GlaxoSmithKlineTerminadoEnfermedad Pulmonar Obstructiva CrónicaChequia
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GlaxoSmithKlineTerminado
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NYU Langone HealthNational Cancer Institute (NCI)TerminadoCáncer de pulmónEstados Unidos