Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy Obese Volunteers
11 de diciembre de 2018 actualizado por: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of JNJ-28431754 in Otherwise Healthy Obese Male and Female Subjects
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of canagliflozin (JNJ-28431754) in healthy obese volunteers.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will be a single-center, randomized (the treatment is assigned by chance), double-blind (neither investigator nor volunteer knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), ascending multiple dose study (increasing doses of study medication) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in otherwise healthy obese volunteers.
The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and an end of study (or follow-up) phase.
Volunteers will be assigned to 5 cohorts (groups) made up of 16 otherwise healthy obese men and women.
Within each group, 12 volunteers will be given canagliflozin once or twice daily and 4 volunteers will be given placebo (inactive medication) once or twice daily for 14 days.
The dose of canagliflozin will be different for each of the 5 groups and the second group will not begin treatment until at least 21 days after the first group start treatment.
This 21-day gap will be applied to all subsequent groups.
Each volunteer will participate in the study for approximately 58 days.
Tipo de estudio
Intervencionista
Inscripción (Actual)
80
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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Florida
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Miramar, Florida, Estados Unidos
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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
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Volunteers must have a body mass index (BMI = weight in kg/height in m2) of 30.0 to 39.9 kg/m2
- Volunteers must be non-diabetic as confirmed by fasting plasma glucose <126 mg/dL
- Volunteers must be non-smoker or non-tobacco users (not smoked cigarettes or used tobacco-containing products for 3 months prior to screening)
Exclusion Criteria:
- History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
- History of having taken anti-obesity medications (prescription or non-prescription) within 3 months of the screening visit, or anticipates a need to take any of these drugs during the course of the study
- History of gastric banding, gastric bypass or other gastric-reduction surgery
- History of eating disorder or recent significant changes in body weight due to dieting or nutritional treatment
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cohort 1
Each volunteer will receive a total daily dose of 30 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
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A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Otros nombres:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
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Experimental: Cohort 2
Each volunteer will receive a total daily dose of 100 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
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A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Otros nombres:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
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Experimental: Cohort 3
Each volunteer will receive a total daily dose of 300 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
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A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Otros nombres:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
Experimental: Cohort 4
Each volunteer will receive a total daily dose of 600 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Otros nombres:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
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Experimental: Cohort 5
Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) twice daily (600 mg total daily dose) or placebo (inactive medication) twice daily on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
Otros nombres:
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in urine glucose excretion per day
Periodo de tiempo: Day -1 (Baseline) up to Day 17
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The change from baseline in urine excretion per day will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 17
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Change from baseline in urine glucose excretion per hour
Periodo de tiempo: Day -1 (Baseline) up to Day 17
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The change from baseline in urine excretion per hour will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 17
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Visual analog scale (VAS) scores related to hunger, satiety, fullness and prospective food consumption
Periodo de tiempo: Day -2 up to Day 17
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Visual analog scale (VAS) scores will be obtained from the VAS questionnaire.
In the VAS questionnaire, volunteers mark a point on a line (drawn between 2 statements) to indicate how they feel about the statements.
The statements about hunger are as follows: "I am not hungry at all" and "I have never been hungrier".
Other statements relate to satiety (feeling satisfied), feeling full and prospective food consumption.
Scores will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -2 up to Day 17
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Change from baseline in mean 24-hour plasma glucose concentrations
Periodo de tiempo: Day -1 (Baseline) up to Day 16
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The change from baseline in mean 24-hour plasma glucose concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 16
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Renal threshold for glucose excretion
Periodo de tiempo: Up to Day 17
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The point at which glucose starts to appear in the urine is known as the renal threshold.
The way in which the renal threshold varies in relation to the dose of canagliflozin (JNJ-28431754) will be calculated.
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Up to Day 17
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Change from baseline in mean 24-hour plasma insulin concentrations
Periodo de tiempo: Day -1 (Baseline) up to Day 14
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The change from baseline in mean 24-hour plasma insulin concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
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Change from baseline in mean 24-hour plasma C-peptide concentrations
Periodo de tiempo: Day -1 (Baseline) up to Day 14
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The change from baseline in mean 24-hour plasma C-peptide concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
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Change from baseline in glucose excursions (after breakfast)
Periodo de tiempo: Day -1 (Baseline) up to Day 14
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Defined as the difference between the maximum glucose values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
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Change from baseline in insulin excursions (after breakfast)
Periodo de tiempo: Day -1 (Baseline) up to Day 14
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Defined as the difference between the maximum insulin values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
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Change from baseline in beta cell function
Periodo de tiempo: Day -1 (Baseline) up to Day 14
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Beta cell function will be calculated from the glucose, insulin, and C-peptide measurements taken post-breakfast on Day -1 up to Day 14. Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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)
14 de junio de 2007
Finalización primaria (Actual)
5 de diciembre de 2007
Finalización del estudio (Actual)
5 de diciembre de 2007
Fechas de registro del estudio
Enviado por primera vez
20 de diciembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
20 de diciembre de 2012
Publicado por primera vez (Estimar)
25 de diciembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de diciembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
11 de diciembre de 2018
Última verificación
1 de diciembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR013765
- 28431754NAP1008 (Otro identificador: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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