- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02034578
Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
9 de junio de 2016 actualizado por: Bristol-Myers Squibb
Study of Apixaban Oral Solution Bioavailability When Administered Through a Nasogastric Tube in Healthy Subjects
The purpose of this study is to assess the bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban solution administered orally in healthy subjects
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
75
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
- Parexel Baltimore Early Phase Clinical Unit
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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 45 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Any history or evidence of abnormal bleeding or coagulation disorders, intracranial hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted in anemia within the past 1 year) or coagulation disorders in a first degree relative
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Arm A: Apixaban
Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via oral syringe
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Otros nombres:
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Experimental: Arm B: Apixaban
Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via nasogastric tube (NGT) immediately followed by 60 mL of D5W via NGT
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Otros nombres:
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Experimental: Arm C: Apixaban
Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via NGT immediately followed by 60 mL of infant formula via NGT
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban
Periodo de tiempo: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h.
Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability.
Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL).
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death
Periodo de tiempo: Day 1 to Day 12
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Day 1 to Day 12
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Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban
Periodo de tiempo: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 hour (h), 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period.
Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability.
Maximum observed plasma concentration (Tmax) was measured in hours (h).
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban
Periodo de tiempo: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period.
Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability.
AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL).
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban
Periodo de tiempo: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period.
Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability.
AUC(0-INF) was measured in ng*h/mL.
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Mean Plasma Elimination Half-Life (T-HALF) of Apixaban
Periodo de tiempo: Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period.
Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability.
T-HALF was measured in hours (h).
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Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3
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Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings
Periodo de tiempo: Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3
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12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done).
Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study.
Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate.
Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.
Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge.
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Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3
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Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests
Periodo de tiempo: Screening, Day -1, Day 4 of Periods, 1, 2, and 3
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Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests.
Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX).
Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX.
High lymphocytes: if value > 7.500 10^3 cells/ µL.
Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL.
High creatine kinase: if value > 1.5* ULN.
Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX.
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Screening, Day -1, Day 4 of Periods, 1, 2, and 3
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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
1 de julio de 2011
Finalización primaria (Actual)
1 de agosto de 2011
Finalización del estudio (Actual)
1 de agosto de 2011
Fechas de registro del estudio
Enviado por primera vez
10 de enero de 2014
Primero enviado que cumplió con los criterios de control de calidad
10 de enero de 2014
Publicado por primera vez (Estimar)
13 de enero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de julio de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2016
Última verificación
1 de junio de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CV185-091
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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