A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
18 de junio de 2018 actualizado por: Pfizer
A Phase 1, Single-dose, Randomized, 4-treatment, 4-period Crossover, Placebo- And Positive-controlled, Double-blind (Open-label For Positive Control), Sponsor-open Study To Determine The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy adult subjects.
This is conducted as part of standard drug development.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
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 healthy male subjects, between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 17.5 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 the time of dosing).
- History of cerebrovascular accident, transient ischemic attack (TIA), or traumatic brain injury.
- History of seizures or history or physical examination findings (eg localizing signs on neurologic examination) suggestive of structural central nervous system (CNS) abnormalities which may place patient at increased risk of seizures.
- History of orthostatic blood pressure changes or clinically significant orthostatic symptoms.
- Self reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PF-04447943 low dose
25 mg of PF-04447943
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Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
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Experimental: PF-04447943 high dose
100 mg of PF-04447943
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Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
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Comparador de placebos: Placebo
Matching placebo for PF-04447943
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Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
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Comparador activo: Moxifloxacin
400 mg of moxifloxacin
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Single oral dose of moxifloxacin administered as tablet
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose
Periodo de tiempo: 0.5 hour post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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0.5 hour post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
Periodo de tiempo: 1 hour post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
1 hour post-dose
|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
Periodo de tiempo: 2 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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2 hours post-dose
|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
Periodo de tiempo: 3 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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3 hours post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
Periodo de tiempo: 4 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
4 hours post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
Periodo de tiempo: 8 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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8 hours post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
Periodo de tiempo: 12 hours post-dose
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Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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12 hours post-dose
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
Periodo de tiempo: 24 hours post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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24 hours post-dose
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
Periodo de tiempo: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis.
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0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
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Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
Periodo de tiempo: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
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Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
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Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
Periodo de tiempo: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
Periodo de tiempo: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Least square mean of QRS interval measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.
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Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
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Number of Participants With Physical Examination Abnormalities
Periodo de tiempo: Baseline (Pre-dose)
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Full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.
Physical examination abnormalities were judged by the investigator.
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Baseline (Pre-dose)
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Number of Participants With Electrocardiogram (ECG) Abnormalities
Periodo de tiempo: Baseline up to 24 hours post-dose
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Criteria for ECG abnormalities: maximum QTc corrected for heart rate using Bazett's formula (QTcB) and QTcF interval (450 to less than [<] 480 msec, 480 to <500 msec, greater than or equal to [>=] 500 msec; increase from baseline [IFB] >=30 msec and <60 msec, IFB >=60 msec).
Baseline was defined as the average of the means obtained from the 3 sets of triplicate measurements taken at -1, -0.5 and 0 hours pre-dose on Day 1 within each intervention period.
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Baseline up to 24 hours post-dose
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Number of Participants With Vital Sign Abnormalities
Periodo de tiempo: Baseline (Pre-dose) up to 24 hours post-dose
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Criteria for vital sign abnormalities: supine and standing pulse rate <40 bpm or greater than (>) 120 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, maximum (max.)
increase from baseline (IFB) and decrease from baseline (DFB) in supine and standing SBP of >=30 mmHg, maximum IFB and DFB in supine and Standing DBP of >=20 mmHg.
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Baseline (Pre-dose) up to 24 hours post-dose
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Number of Participants With Laboratory Test Abnormalities
Periodo de tiempo: Baseline (Pre-dose) up to 24 hours post-dose
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Hemoglobin(Hgb), hematocrit, red blood cell(RBC)<0.8*lower
limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume <0.9*LLN, >1.1*upper limit of normal(ULN), platelet<0.5*LLN,>1.75*ULN,
lymphocyte, neutrophil<0.8*LLN,
>1.2*ULN, basophil, eosinophil, monocyte>1.2*ULN,
white blood cell(WBC)<0.6*LLN,>1.5*ULN,
reticulocytes<0.5*LLN,>1.5*ULN;
bilirubin>1.5*ULN,
aspartate aminotransferase(AT), alanine AT, alkaline phosphatase>3.0*ULN,
protein, albumin<0.8*LLN,>1.2*ULN;
blood urea nitrogen, creatinine>1.3*ULN,
uric acid>1.2*ULN;
sodium<0.95*LLN,>1.05*ULN,
potassium, chloride, calcium, bicarbonate<0.9*LLN,>1.1*ULN;
glucose<0.6*LLN,
>1.5*ULN, HbA1c>1.3*ULN,
creatinine kinase>2*ULN; urine-specific gravity<1.003,>1.030,
pH<4.5,>8,
WBC, RBC>=20, bacteria>20, urobilinogen, glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin>=1; thyroid stimulating hormone<0.8*LLN,>1.2*ULN;
cholesterol, triglycerides>1.3*ULN,
high density lipoprotein cholesterol(DL-C) <0.8*LLN, low DL-C>1.2*ULN.
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Baseline (Pre-dose) up to 24 hours post-dose
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Maximum Plasma Concentration (Cmax) of PF-04447943
Periodo de tiempo: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943
Periodo de tiempo: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943
Periodo de tiempo: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Area under the plasma concentration-time from time zero to time of last measurable concentration.
Observed using the linear/log trapezoidal method.
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Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 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 (Actual)
29 de junio de 2016
Finalización primaria (Actual)
20 de octubre de 2016
Finalización del estudio (Actual)
20 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
25 de mayo de 2016
Primero enviado que cumplió con los criterios de control de calidad
25 de mayo de 2016
Publicado por primera vez (Estimar)
30 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de diciembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de junio de 2018
Última verificación
1 de junio de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B0401018
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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