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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02804399
A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
22 de agosto de 2018 actualizado por: Pfizer
A Phase One, Open Label, Two-period, Two-treatment, Fixed Sequence, Cross-over Study To Estimate The Effect Of Multiple Dose Rifampin On The Single Dose Pharmacokinetics Of Pf-06463922 In Healthy Volunteers.
The purpose of this study is to estimate the effect of rifampin on the single dose PK of PF-06463922.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This will be a Phase 1, open-label, 2-period, 2-treatment, fixed-sequence, cross-over study in approximately 12 healthy subjects employing administration of a single oral dose of PF-06463922 in the fasted state alone, and with multiple dosing of rifampin 600 mg once a day to estimate the effect of multiple dose rifampin on the single dose PK of PF-06463922.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
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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Connecticut
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New Haven, Connecticut, Estados Unidos, 06511
- Pfizer New Haven Clinical Research 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 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- Any condition possibly affecting drug absorption
- Positive urine drug screen
- History of HIV, Hep B or Hep C
- History of regular alcohol consumption
- History of cardiac arrhythmia, history of AV block, history of symptomatic bradycardia, history of QTc prolongation
- History of pancreatitis or hyperlipidemia, elevated lipase
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: Otro
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: all subjects
subjects will receive a 100 mg single oral dose of PF-06463922 followed by a 100 mg single dose of PF-06463922 combined with 600 mg QD dose of rifampin with at least 10 days of washout period between two PF-06463922 doses.
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100 mg oral dose on day 1 in period 1 and on day 8 in period 2
Otros nombres:
600 mg QD from day 1 to day 12 in period 2.
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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Plasma AUCinf for PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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AUCinf is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma Cmax for PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Cmax is the maximum observed plasma concentration.
PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Plasma AUClast for PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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AUClast is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma Tmax for PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Tmax is the time for maximum observed plasma concentration (Cmax).
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma t1/2 for PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Terminal plasma half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma CL/F for PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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CL/F is the apparent oral clearance.
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma Vz/F for PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg administration with rifampin in Period 2.
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Vz/F is the apparent volume of distribution (only after single dose).The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg administration with rifampin in Period 2.
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Plasma AUClast for PF-06895751 When PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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AUClast was the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
PF-06895751 was the metabolite of PF-06463922.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma AUCinf for PF-06895751 When PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
PF-06895751 was the metabolite of PF-06463922.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma Tmax for PF-06895751 When PF-06463922 Given Alone and With Rifampin.
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Tmax was the time for maximum observed plasma concentration (Cmax).
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
PF-06895751 was the metabolite of PF-06463922.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma t1/2 for PF-06895751 When PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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T1/2 was the terminal plasma half-life.
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
PF-06895751 was the metabolite of PF-06463922.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma Cmax for PF-06895751 When PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Cmax was the maximum observed plasma concentration.
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
PF-06895751 was the metabolite of PF-06463922.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for Cmax (MRCmax) of PF-06463922 and Its Metabolite: When PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Cmax was the maximum observed plasma concentration of PF-06463922 and PF-06895751 ( metabolite of PF-06463922).
The molecular weight adjusted metabolite/parent ratio (PF-06895751/PF-06463922) for Cmax was presented.
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUClast (MRAUClast) of PF-06463922 and Its Metabolite: When PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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AUClast was the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration of PF-06463922 and PF-06895751 ( metabolite of PF-06463922).
The molecular weight adjusted metabolite/parent ratio (PF-06895751/PF-06463922) for AUClast was presented.
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
PF-06895751 was the metabolite of PF-06463922.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Plasma Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUCinf (MRAUCinf) of PF-06463922 and Its Metabolite: When PF-06463922 Given Alone and With Rifampin
Periodo de tiempo: Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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AUCinf was the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time of PF-06463922 and PF-06895751 ( metabolite of PF-06463922).
The molecular weight adjusted metabolite/parent ratio (PF-06895751/PF-06463922) for AUCinf was presented.
The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
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Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With End of Study Abnormal Laboratory Findings Meeting the Criteria of Potentially Significant Clinical Concern
Periodo de tiempo: Baseline to about 18 days after the first PF-06463922 dose
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The total number of participants with laboratory test abnormalities was assessed.
Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests (including follicle-simulating hormone[FSH], urine drug screening, hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HBcAb], hepatitis C virus antibody [HCVAb] and human immunodeficiency virus [HIV].
Clinical significance was judged by the investigator.
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Baseline to about 18 days after the first PF-06463922 dose
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Number of Participants With Physical Examination Findings Meeting the Criteria of Potentially Significant Clinical Concern
Periodo de tiempo: Baseline to about 18 days after the first PF-06463922 dose.
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A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.
The limited or abbreviated physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.
Clinical significance was judged by the investigator.
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Baseline to about 18 days after the first PF-06463922 dose.
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Number of Participants With Changes From Baseline and Absolute Values in Vital Signs Meeting the Criteria of Potentially Significant Clinical Concerns
Periodo de tiempo: Baseline to about 18 days after the first PF-06463922 dose.
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Criteria for potentially clinically important changes in vital signs were defined as: supine and standing systolic blood pressure (SBP) of less than (<90) millimeters of mercury (mm Hg) or change in supine and standing SBP more than or equal to (>=) 30 mm Hg; supine and standing diastolic blood pressure (DBP) of < 50 mm Hg or change in supine and standing DBP of >= 20 mm Hg; supine and standing pulse rate of < 40 or >120 beats per minute (bpm).
Figure "99999" signifies data not measurable/applicable.
Maximum Decrease is abbreviated as Max.Dec., and Maximum Increase is abbreviated as Max.Inc.
n is the number of participants contributing to the parameter, not applicable is abbreviated as N/A.
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Baseline to about 18 days after the first PF-06463922 dose.
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Number of Participants With Electrocardiogram (ECG) Findings Meeting the Criteria of Potentially Significant Clinical Concerns
Periodo de tiempo: Baseline to about 18 days after the first PF-06463922 dose.
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PR interval was the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization.
Criteria for potentially clinically important changes (chg) in ECG were defined as: absolute values of PR interval >=200 to <220 msec, >=220 to <240 msec, >=240 to <260 msec and >=260 msec.
Increase from baseline >=40, <60, >=60 and <80, >=80, and relative change from baseline >25%.
The beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formular (QTCF) of 450 to <480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec of >=60 msec.
Maximum is abbreviated as Max.
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Baseline to about 18 days after the first PF-06463922 dose.
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Number of Participants With Concomitant Treatments Meeting the Criteria of Potentially Significant Clinical Concerns
Periodo de tiempo: Baseline to about 18 days after the first PF-06463922 dose.
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Participants abstained from all concomitant treatments, except for the treatment of adverse events.
Limited use of non-prescription medications that were not believed to affect participant safety or the overall results of the study might be permitted on a case by case basis following approval by the sponsor.
All participants were questioned about concomitant treatment at each clinic visit.
Treatments taken within 28 days before the first dose of study investigational product were documented as a prior treatment.
Treatment taken after the first dose of study investigational product were documented as concomitant treatments.
Females taking hormone replacement therapy might be eligible to participate in this study if they were willing to discontinue therapy at least 28 days prior to the first dose of study treatment and remained off hormonal therapy for duration of the study.
Clinical significance was judged by the investigator.
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Baseline to about 18 days after the first PF-06463922 dose.
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-Related)
Periodo de tiempo: Baseline to about 18 days after the first PF-06463922 dose.
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An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a casual relationship with the treatment or usage.
A serious adverse event (SAE) was any untoward medical occurrence at any dose that: 1) resulted in death; 2) was life threatening (immediate risk of death); 3) required inpatient hospitalization or prolongation of existing hospitalization; 4) resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); 5) resulted in congenital anomaly/birth defect.
TEAE included both non-serious adverse events and serious adverse events.
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Baseline to about 18 days after the first PF-06463922 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 (Actual)
1 de julio de 2016
Finalización primaria (Actual)
1 de octubre de 2016
Finalización del estudio (Actual)
1 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2016
Primero enviado que cumplió con los criterios de control de calidad
14 de junio de 2016
Publicado por primera vez (Estimar)
17 de junio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
22 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes antibacterianos
- Agentes leprostáticos
- Inductores de enzimas de citocromo P-450
- Inductores de citocromo P-450 CYP3A
- Agentes antituberculosos
- Antibióticos, Antituberculosos
- Inductores de citocromo P-450 CYP2B6
- Inductores de citocromo P-450 CYP2C8
- Inductores del citocromo P-450 CYP2C19
- Inductores de citocromo P-450 CYP2C9
- Rifampicina
Otros números de identificación del estudio
- B7461011
- RIFAMPIN DDI STUDY (Otro identificador: Alias Study Number)
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-06463922
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PfizerYa no está disponibleCáncer de pulmón de células no pequeñas ALK positivo o ROS1 positivoEstados Unidos
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PfizerReclutamientoCarcinoma de pulmón de células no pequeñas ALK+Francia
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PfizerActivo, no reclutandoNSCLC | Cáncer de pulmón de células no pequeñasPorcelana, España, Taiwán, Singapur, Francia, India, Japón, Estados Unidos
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PfizerTerminadoCarcinoma de pulmón de células no pequeñasPorcelana
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PfizerTerminadoVoluntarios Saludables | Insuficiencia hepática moderada | Insuficiencia hepática graveEstados Unidos
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PfizerTerminadoEstudio de dosis única del metabolismo de [14C]lorlatinib (PF-06463922) en voluntarios varones sanosVoluntarios SaludablesEstados Unidos
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PfizerTerminadoCáncer de pulmón de células no pequeñasEstados Unidos, Australia, Japón, Corea, república de, España
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PfizerActivo, no reclutandoCarcinoma de pulmón de células no pequeñasItalia, Canadá, España, Estados Unidos, Porcelana, Reino Unido, Francia, Japón, Singapur, Taiwán, Australia, Países Bajos, India, Hong Kong, Argentina, Bélgica, Chequia, Alemania, México, Polonia, Corea del Sur, Turquía (Türkiye), Rusia