- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01857895
Feasibility Study of Exenatide by Continuous Subcutaneous Infusion
17 de octubre de 2017 actualizado por: GlaxoSmithKline
An Open-Label Exploratory Study to Investigate the Feasibility of Administering Exenatide by Continuous Subcutaneous Infusion to Healthy Subjects
This is an open-label study to investigate the feasibility of administering exenatide by continuous subcutaneous infusion to healthy subjects.
Study will consist of two parts i.e.
Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours followed by a follow-up visit 10 to 14 days after discharge from clinic.
In Part B approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
10
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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Maryland
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Baltimore, Maryland, Estados Unidos, 21225
- 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 60 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria
- Male/females aged between 18 and 60 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures and objectives.
- Body Mass Index within the range 18 to 35 kilograms/meter squared (kg/m^2) inclusive.
- A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone > 40 milli international unit/mililiter (mL) and estradiol <40 picogram/mL (<147 picomoles/Liter) 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 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 enrollment.
- Child-bearing potential females must agree to use one of the contraception methods. This criterion must be followed from the time of the first dose of study medication until follow up visit.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Based on QT interval corrected for heart rate (QTc) of single electrocardiogram (ECG): QTc by Fridericia's formula <450 millisecond (msec).
- Aspartate aminotransferase and Alanine aminotransferase <2x upper limit of normal (ULN); alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Exclusion Criteria
- Subjects with a personal or family history of thyroid carcinoma or Type 2 Familial Endocrine Neoplasia.
- History of uncorrected thyroid dysfunction or an abnormal thyroid functions as assessed by thyroid stimulating hormones.
- Subjects with a history of severe gastrointestinal disease, or abnormal renal function.
- Subjects with previous exposure to a Glucagon-like peptide-1 mimetic.
- History of chronic or acute pancreatitis. Note: Subjects with a lipase value above 1.5X ULN at screening are excluded.
- Current or chronic history of liver disease, or hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
Criteria Based Upon Diagnostic Assessments
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive pre-study drug/alcohol screen.
- A subject with a positive urine cotinine test result will be excluded from the study unless in the judgment of the Investigator the subject will be able to abstain from using tobacco for the duration of the in-house period of the study.
- A positive test for human immuno virus antibody.
Other Criteria
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- 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.
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 de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Exenatide infusion in Part A
Subjects in Part A will receive exenatide as a subcutaneous infusion at a constant rate for 24 hours.
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Prefilled pen containing 2.4 mL of drug will be transferred into MiniMed Paradigm Real-Time Revel device for subcutaneous infusion.
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Experimental: Exenatide infusion in Part B
Subjects in Part B will receive exenatide with daily increases in the infusion rate.
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Prefilled pen containing 2.4 mL of drug will be transferred into MiniMed Paradigm Real-Time Revel device for subcutaneous infusion.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Characterization of interruptions or deviations from prescribed exenatide infusion in Part A
Periodo de tiempo: 2 days
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To investigate the feasibility of administering exenatide via continuous subcutaneous infusion
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2 days
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Characterization of interruptions or deviations from prescribed exenatide infusion in Part B
Periodo de tiempo: 8 days
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To investigate the feasibility of administering exenatide via continuous subcutaneous infusion
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8 days
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Infusion rate adjustments when nausea/vomiting occurs in Part B
Periodo de tiempo: 8 days
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To investigate the feasibility of administering exenatide via continuous subcutaneous infusion.
Infusion rate adjustment will be done to achieve tolerable infusion rate when nausea/vomiting occurs
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8 days
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Number of participants with adverse events (AEs) in Part A
Periodo de tiempo: 17 days
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AEs will be collected from the Day -1 and until the follow-up contact.
AE data will be collected to evaluate the ability to monitor and maintain acceptable safety
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17 days
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Number of participants with AEs in Part B
Periodo de tiempo: 23 days
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AEs will be collected from the Day -1 and until the follow-up contact.
AE data will be collected to evaluate the ability to monitor and maintain acceptable safety
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23 days
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Laboratory parameter assessment in Part A
Periodo de tiempo: 17 days
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Laboratory parameters include: hematology, clinical chemistry, and urinalysis
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17 days
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Laboratory parameter assessment in Part B
Periodo de tiempo: 23 days
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Laboratory parameters include: hematology, clinical chemistry, and urinalysis
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23 days
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Vital sign assessment in Part A
Periodo de tiempo: 17 days
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Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
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17 days
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Vital sign assessment in Part B
Periodo de tiempo: 23 days
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Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate
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23 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pharmacokinetic (PK) profile of exenatide in Part A
Periodo de tiempo: PK samples will be collected at pre-dose, and at 0.5, 1, 2, 4, 6, 10, 14, 24, and 26 hours post dose.
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PK parameters include: area under concentration time curve from time 0 to 24 hours (AUC0 to24), maximum observed concentration from time 0 to 24 hours (Cmax0 to 24), and average concentration from time 0 to 24 hours (Cavg0 to 24) versus time
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PK samples will be collected at pre-dose, and at 0.5, 1, 2, 4, 6, 10, 14, 24, and 26 hours post dose.
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Pharmacokinetic (PK) profile of exenatide in Part B
Periodo de tiempo: 8 days
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PK parameters include: AUC0-24, Cmax0 to 24, and Cavg0 to 24 versus time for each of 7 days and AUC0 to 168, Cmax0 to 168, and Cavg0 to 168 versus time over entire infusion period.
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8 days
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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)
16 de mayo de 2013
Finalización primaria (Actual)
1 de noviembre de 2013
Finalización del estudio (Actual)
1 de noviembre de 2013
Fechas de registro del estudio
Enviado por primera vez
16 de mayo de 2013
Primero enviado que cumplió con los criterios de control de calidad
16 de mayo de 2013
Publicado por primera vez (Estimar)
20 de mayo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de octubre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
17 de octubre de 2017
Última verificación
1 de octubre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 200016
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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Protocolo de estudio
Identificador de información: 200016Comentarios 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: 200016Comentarios 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: 200016Comentarios 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: 200016Comentarios 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: 200016Comentarios 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: 200016Comentarios 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: 200016Comentarios 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. .