A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects
16 de julio de 2015 actualizado por: Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Ascending Oral Doses Of Pf-06409577 In Healthy Adult Subjects
PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy.
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 in healthy adult subjects.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
39
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
-
-
-
Brussels, Bélgica, B-1070
- Pfizer Clinical Research Unit
-
-
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 55 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy male, or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
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 paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cohort 1: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Experimental: Cohort 2: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Experimental: Cohort 3: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Experimental: Cohort 4: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Experimental: Cohort 5: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Experimental: Cohort 6: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Experimental: Cohort 7: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Experimental: Cohort 8: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Experimental: Cohort 9: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of Participants With Adverse Events (AEs)
Periodo de tiempo: 0-48 hours post dose
|
0-48 hours post dose
|
|
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Periodo de tiempo: 0-48 hours post dose
|
0-48 hours post dose
|
|
Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance
Periodo de tiempo: 0-48 hours post dose
|
0-48 hours post dose
|
|
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
Periodo de tiempo: 0-48 hours post dose
|
0-48 hours post dose
|
|
Number of Participants With Echocardiogram Findings of Potential Clinical Importance
Periodo de tiempo: 0-48 hours post dose
|
0-48 hours post dose
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577
Periodo de tiempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
|
Area under the plasma concentration time-curve from zero to time 24 hours post dose (AUC24)
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577
Periodo de tiempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577
Periodo de tiempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity).
It is obtained from AUC (0 - t) plus AUC (t - infinity).
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
|
Maximum Observed Plasma Concentration (Cmax) for PF-06409577
Periodo de tiempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
Maximum Observed Plasma Concentration (Cmax)
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577
Periodo de tiempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
|
Plasma Decay Half-Life (t1/2) for PF-06409577
Periodo de tiempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
Plasma Decay Half-Life (t1/2)
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
|
Apparent Oral Clearance (CL/F) for PF-06409577
Periodo de tiempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
|
Apparent Volume of Distribution (Vz/F) for PF-06409577
Periodo de tiempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
|
Total amount of PF-06409577 excreted in the urine over 24 hours (Ae24)
Periodo de tiempo: 0-24 hours post dose
|
Total amount of unchanged drug excreted in the urine over 24 hours.
|
0-24 hours post dose
|
|
Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24)
Periodo de tiempo: 0-24 hours post dose
|
Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose.
|
0-24 hours post dose
|
|
Renal clearance for PF-06409577
Periodo de tiempo: 0-24 hours post dose
|
Renal clearance of a drug is a measure of the rate at which a drug is excreted unchanged into urine.
|
0-24 hours post dose
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 noviembre de 2014
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
6 de noviembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
6 de noviembre de 2014
Publicado por primera vez (Estimar)
10 de noviembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de julio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
16 de julio de 2015
Última verificación
1 de julio de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- B7881001
- FIH (Otro identificador: Alias Study Number)
- 2014-004022-18 (Número EudraCT)
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. .