Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
14 de abril de 2017 actualizado por: Eisai Co., Ltd.
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50 milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged 50 to 85 years.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
16
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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Fukuoka, Japón
- Eisai Trial 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
50 años a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Healthy males and females
- Aged 50 to 85 years, inclusive at time of consent
- Body mass index (BMI) of 17.6 to 32 kilograms per meters squared (kg/m^2) at Screening
Exclusion Criteria:
- Personal or family history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (eg, history of head trauma or concussion, previous alcohol abuse, substance abuse)
- A history of cerebrovascular accident or non-vasovagal-related loss of consciousness
- Any clinically significant findings on neurological examination
- A family history of Long QT Syndrome or a presence of other risk factors for Torsades de Pointes (TDP), such as hypokalemia, hypomagnesemia, or hypocalcemia
- History of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease
- A history of gastrointestinal surgery that may affect the pharmacokinetic profile of E2609 (eg, hepatectomy, nephrotomy, digestive organ resection)
- A known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy
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: E2609 50 mg
Participants will receive E2609 50 milligrams (mg) orally once a day for 14 days.
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tablet
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Comparador de placebos: Placebo
Participants will receive matching placebo orally once a day for 14 days.
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tableta
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of participants with any serious adverse event and number of participants with any non-serious adverse event
Periodo de tiempo: up to Day 35 (Termination/Visit 5)
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An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
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up to Day 35 (Termination/Visit 5)
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Number of participants with an abnormal, clinically significant laboratory test value
Periodo de tiempo: Screening; Baseline; Days 4, 8, 11, 14, 20 (Out-Patient Follow-up), and 35 (Termination/Visit 5); up to Day 62 (unscheduled Follow-up visits)
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Laboratory test values will be assigned a low/normal/high (LNH) classification according to whether the value was below (L), within (N), or above (H) the laboratory parameter's reference range.
Clinical significance will be determined by the Investigator.
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Screening; Baseline; Days 4, 8, 11, 14, 20 (Out-Patient Follow-up), and 35 (Termination/Visit 5); up to Day 62 (unscheduled Follow-up visits)
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Number of participants with an abnormal, clinically significant vital sign value
Periodo de tiempo: Screening; Baseline; up to Day 62
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Vital sign measurements (ie, systolic and diastolic blood pressure [BP] [millimeters of mercury (mmHg)], heart rate [beats per minute], respiratory rate [breaths per minute], body temperature [centigrade]) will be obtained in the supine position by a validated method.
Clinical significance will be determined by the Investigator.
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Screening; Baseline; up to Day 62
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Number of participants with an abnormal, clinically significant electrocardiogram (ECG) finding
Periodo de tiempo: Screening; Baseline; up to Day 62
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Twelve-lead standard ECGs will be recorded in triplicate.
ECGs will be recorded after the participant has been in the supine position for at least 10 minutes before and during the reading.
In addition, all ECGs will be obtained before blood draws.
Clinical significance will be determined by the Investigator.
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Screening; Baseline; up to Day 62
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Clinical assessment of suicidality per the suicidality rating scale
Periodo de tiempo: Baseline (Day -1), 24 hours after dosing (Day 2), Day 15, Day 20, Day 35 (Termination/Visit 5), up to Day 62 (unscheduled Follow-up visits)
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The suicidality rating scale will rate a participant's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
The decision to classify an isolated suicidality rating scale response as an adverse event will be exercised through medical and scientific judgment.
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Baseline (Day -1), 24 hours after dosing (Day 2), Day 15, Day 20, Day 35 (Termination/Visit 5), up to Day 62 (unscheduled Follow-up visits)
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Mean quality of sleep score per the Waketime Questionnaire, if necessary
Periodo de tiempo: up to Day 62
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Participants reporting adverse events (AEs) relating to abnormal dreams, nightmares, or sleep terrors will be questioned using the Waketime Questionnaire which is comprised of 5 individual questions.
A participant is asked to rate the quality of their sleep as: 1, Very sound or restful; 2, Sound or restful; 3, Average quality; 4, Restless; or 5, Very restless.
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up to Day 62
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean maximum observed concentration (Cmax) of E2609 and metabolites on Day 1 and Day 14
Periodo de tiempo: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Cmax is defined as the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Cmax.
Cmax will be summarized as the mean and standard deviation for all participants.
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Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Mean minimum observed concentration (Cmin) of E2609 and metabolites on Day 1 and Day 14
Periodo de tiempo: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Cmin is defined as the minimum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Cmin.
Cmin will be summarized as the mean and standard deviation for all participants.
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Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Median time from dosing to reach Cmax (tmax) of E2609 and metabolites on Day 1 and Day 14
Periodo de tiempo: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Tmax.
Tmax will be summarized as the median for all participants.
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Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Mean area under the concentration-time curve (AUC) from time 0 to 24 hours for E2609 and metabolites on Day 1 and Day 14
Periodo de tiempo: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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AUC represents the total drug exposure over a defined period of time.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC(0-24h).
AUC(0-24h) will be summarized as the mean and standard deviation for all participants and will be expressed in nanograms x hour per milliliter (ng*hr/mL).
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Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Mean terminal elimination half-life (t1/2) following the last day of dosing (Day 14) of E2609 and metabolites
Periodo de tiempo: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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Terminal half-life is the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine t1/2.
t1/2 will be summarized as the mean and standard deviation for all participants and will be expressed in hours.
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Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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Mean average concentration calculated as AUCss/tau (Css,av), where tau is the dosing interval, of E2609 and metabolites on Day 1 and Day 14
Periodo de tiempo: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Css,av is the average steady-state concentration of a drug.
Steady state will be achieved when the rate of E2609 administration and the rate of E2609 elimination are equal.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine the Css,av.
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Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Mean accumulation ratio for AUC, Cmax, and Cmin (Rac) for E2609 and metabolites on Day 1 and Day 14
Periodo de tiempo: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Rac is equal to the ratio of the AUC during a dosage interval at steady state to the AUC of a dosage interval after the first dose.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine Rac.
Rac will be summarized as the mean and standard deviation for all participants
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Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Apparent clearance at steady state (CLss/F) of E2609 on Day 14
Periodo de tiempo: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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CLss/F is the rate and extent of absorption and clearance of E2609 from the plasma.
Plasma concentrations of E2609 and metabolites will be analyzed using a non-compartmental analysis approach to determine CLss/F.
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Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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Number of participants with polymorphisms of N-acetyltransferase 2 (NAT2)
Periodo de tiempo: Day 1
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NAT2 genotyping will be conducted, and the predicted phenotype (eg, slow, intermediate, or rapid acetylators) will be used in the statistical analysis to evaluate the relative impact of NAT2 polymorphisms on plasma concentrations of E2609 and/or its metabolites.
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Day 1
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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 (Actual)
14 de febrero de 2017
Finalización primaria (Actual)
29 de marzo de 2017
Finalización del estudio (Actual)
11 de abril de 2017
Fechas de registro del estudio
Enviado por primera vez
10 de febrero de 2017
Primero enviado que cumplió con los criterios de control de calidad
14 de febrero de 2017
Publicado por primera vez (Actual)
16 de febrero de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
14 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- E2609-J081-014
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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