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- Ensayo clínico NCT02079922
A Multiple Dose Study Of PF-06678552 In Healthy Subjects
29 de julio de 2014 actualizado por: Pfizer
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Administration Of Multiple Escalating Oral Doses In Healthy Adult Subjects
PF-06678552 is a new compound proposed for the treatment of hypercholesteremia.
The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
38
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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Brussels, Bélgica, B-1070
- Pfizer 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 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy male and/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
- Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL
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 |
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Experimental: Cohort 1
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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Experimental: Cohort 2
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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Experimental: Cohort 3
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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Experimental: Cohort 4
Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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Experimental: Cohort 5
Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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Experimental: Cohort 6
Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG.
Periodo de tiempo: 0 to 24 days post dose
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0 to 24 days post dose
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Amount of PF-06644927 excreted in urine (Ae) on day 14
Periodo de tiempo: 0-12 hours post dose
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0-12 hours post dose
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Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14
Periodo de tiempo: 0-12 hours post dose
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0-12 hours post dose
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Renal clearance of PF-06644927 (CLr) on day 14
Periodo de tiempo: 0-12 hours post dose
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0-12 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06678552 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 7 relative to day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 14 relative to day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 14 relative to day 1
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Apparent Oral Clearance (CL/F) of PF-06678552 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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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.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Apparent Oral Clearance (CL/F) of PF-06678552 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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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.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 7
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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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.
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14
Periodo de tiempo: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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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.
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0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose
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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
1 de marzo de 2014
Finalización primaria (Actual)
1 de julio de 2014
Finalización del estudio (Actual)
1 de julio de 2014
Fechas de registro del estudio
Enviado por primera vez
4 de marzo de 2014
Primero enviado que cumplió con los criterios de control de calidad
4 de marzo de 2014
Publicado por primera vez (Estimar)
6 de marzo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
31 de julio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2014
Última verificación
1 de julio de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- B7611002
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 PF-06678552
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PfizerTerminado
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PfizerTerminado
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University of FloridaTerminadoSíntomas gastrointestinales | Frecuencia de heces | Tiempo de tránsito gastrointestinalEstados Unidos
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PfizerTerminado
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PfizerTerminado