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- Ensayo clínico NCT05147337
A Study to Assess the Safety and Tolerability of E2511 in Healthy Adult and Elderly Participants
8 de septiembre de 2022 actualizado por: Eisai Inc.
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Healthy Adult and Elderly Subjects
The primary objective of this study is to evaluate the safety, tolerability, and plasma pharmacokinetic (PK) of E2511 following multiple oral doses in healthy adult participants.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
47
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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California
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Glendale, California, Estados Unidos, 91206
- California Clinical Trials Medical Group
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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 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Non-smoking, male, or female, non-Japanese participants age >=18 years and <55 years old (Cohorts 1 to 4) or age >=55 years and <=85 years old (Cohort 8); or Japanese participants age >=20 years and <55 years old (Cohorts 5 to 7) at the time of informed consent
Japanese participants must also satisfy the following requirements:
- Must have been born in Japan of Japanese parents and Japanese grandparents
- Must have lived no more than 5 years outside of Japan
- Must not have changed their lifestyle or habits, including diet, while living outside of Japan
- Weight of at least 50 kilogram (kg) and body mass index (BMI) >=18 and <30 kilogram per square meter (kg/m^2) (Cohorts 1 to 7) or BMI >=18 and <32 kg/m^2 (Cohort 8) at Screening
Exclusion Criteria:
- Females who are breastfeeding or pregnant at Screening or Baseline
Females of childbearing potential who:
- Within 28 days before study entry, did not use a highly effective method of contraception
- Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation.
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
- Evidence of disease within 4 weeks before dosing related to chronic headaches, migraines, joint pain, or other disorders or disease resulting in chronic or intermittent pain
- Any personal or family history of seizures (including febrile seizures) or diagnosis of epilepsy or episode of unexplained loss of consciousness
- Any history of neurological or other medical conditions which in the opinion of the investigator has the potential to reduce seizure threshold
- Any history of gastrointestinal surgery that may affect PK profiles of E2511, example, hepatectomy, nephrectomy, digestive organ resection at Screening
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline
- A prolonged QT/QT interval corrected for heart rate (QTc) interval or a prolonged QT/QTc interval (QT interval corrected for heart rate using Fridericia's formula [QTcF] greater than [>] 450 milliseconds [ms]). A history of risk factors for torsade de pointes
- HR <50 or more than 100 beats per minute at Screening or Baseline (Cohorts 1 through 7); or HR <55 or more than 100 beats per minute at Screening or Baseline (Cohort 8) NOTE: At Baseline, HR must meet the above criteria on 3 assessments (each separated by 15 minutes) to ensure eligibility
- Left bundle branch block
- History of myocardial infarction or active ischemic heart disease
- History of clinically significant arrhythmia or uncontrolled arrhythmia
- Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the C-SSRS
- Any lifetime history of psychiatric disease
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
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cohort 1: E2511 10 mg or Placebo
Non-Japanese adult (greater than or equal to [>=] 18 years and less than [<] 55 years old) participants will receive 10 milligram (mg) E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.
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E2511 tabletas.
E2511 matched placebo tablets.
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Experimental: Cohort 2: E2511 20 mg or Placebo
Non-Japanese adult participants will receive 20 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.
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E2511 tabletas.
E2511 matched placebo tablets.
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Experimental: Cohort 3: E2511 40 mg or Placebo
Non-Japanese adult participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.
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E2511 tabletas.
E2511 matched placebo tablets.
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Experimental: Cohort 4: E2511 80 mg or Placebo
Non-Japanese adult participants will receive 80 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.
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E2511 tabletas.
E2511 matched placebo tablets.
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Experimental: Cohort 5: E2511 20 mg or Placebo
Japanese adult (>=20 years and <55 years old) participants will receive 20 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.
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E2511 tabletas.
E2511 matched placebo tablets.
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Experimental: Cohort 6: E2511 40 mg or Placebo
Japanese adult participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.
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E2511 tabletas.
E2511 matched placebo tablets.
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Experimental: Cohort 7: E2511 80 mg or Placebo
Japanese adult participants will receive 80 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.
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E2511 tabletas.
E2511 matched placebo tablets.
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Experimental: Cohort 8: E2511 40 mg or Placebo
Non-Japanese older (>=55 years and less than or equal to [<=] 85 years old) participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.
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E2511 tabletas.
E2511 matched placebo tablets.
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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 Treatment-emergent Adverse Events (TEAEs)
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Number of Participants With Serious Adverse Events (SAEs)
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Number of Participants With Clinically Significant Abnormal Laboratory Values
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Number of Participants With Clinically Significant Abnormal Vital Signs Values
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Number of Participants With Clinically Significant Abnormal Ambulatory Blood Pressure
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess any suicidality, suicidal behavior, or suicidal ideation.
Any suicidality is emergence of any suicidal ideation or suicidal behavior.
Any suicidal behavior is indicated when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts.
Any suicidal ideation is indicated when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide.
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Number of Participants With Clinically Significant Abnormal Neurological Examination Findings
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings
Periodo de tiempo: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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From Screening up to 14 days after the last dose of study drug (up to 56 days)
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Cmax: Maximum Observed Plasma Concentration for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose
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Css,max: Maximum Observed Plasma Concentration at Steady State for E2511
Periodo de tiempo: Day 14: pre-dose up to 24 hours post-dose
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Day 14: pre-dose up to 24 hours post-dose
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tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose
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tss,max: Time to Reach Maximum Observed Plasma Concentration (Cmax) at Steady State for E2511
Periodo de tiempo: Day 14: pre-dose up to 24 hours post-dose
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Day 14: pre-dose up to 24 hours post-dose
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Css,av: Average Steady State Plasma Concentration for E2511
Periodo de tiempo: Day 14: pre-dose up to 24 hours post-dose
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Day 14: pre-dose up to 24 hours post-dose
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AUC(0-t): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose
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AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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t1/2: Terminal Elimination Phase Half-life for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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PTF: Peak-trough Fluctuation for E2511
Periodo de tiempo: Day 14: pre-dose up to 24 hours post-dose
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Day 14: pre-dose up to 24 hours post-dose
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CL/F: Apparent Total Clearance for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose
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CLss/F: Apparent Total Clearance at Steady State for E2511
Periodo de tiempo: Day 14: pre-dose up to 24 hours post-dose
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Day 14: pre-dose up to 24 hours post-dose
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Vz/F: Apparent Volume of Distribution at Terminal Phase for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Rac: Accumulation Ratio for E2511 Based on Cmax and AUC
Periodo de tiempo: Day 14: pre-dose up to 24 hours post-dose
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Day 14: pre-dose up to 24 hours post-dose
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Rss: Accumulation Ratio for E2511 Based on Time and Concentration
Periodo de tiempo: Day 14: pre-dose up to 24 hours post-dose
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Day 14: pre-dose up to 24 hours post-dose
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in the Concentration of Acetylcholine (ACh) in Cerebrospinal Fluid (CSF)
Periodo de tiempo: Baseline, Day 13
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Baseline, Day 13
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Change From Baseline in Heart Rate (HR)
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Change From Baseline in PR Interval of the ECG (PR), QRS Interval of the ECG (QRS), and QT Interval Corrected for Heart Rate (QTc) of the ECG
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Placebo Corrected Change From Baseline in HR
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Placebo Corrected Change From Baseline in PR, QRS, and QTc Interval
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Number of Participants With Categorical Outliers for HR, PR, QRS and QTc Interval
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Number of Participants With Treatment-emergent T-wave and U-wave abnormalities
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Mean Change From Baseline in 24-hours Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) up to Day 15
Periodo de tiempo: Up to Day 15
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The blood pressure (BP) will be evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the measurement of BP recordings after every 24 hours.
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Up to Day 15
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Mean Change From Baseline in Day-time, Night-time, and Hourly SBP and DBP
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Mean Change From Baseline in Day-time, Night-time, and Hourly HR
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Mean Change From Baseline in Day-time, Night-time, and Hourly Mean Arterial Pressure (MAP) and Pulse Pressure (PP)
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Placebo Corrected Mean Change From Baseline in 24-hours SBP and DBP up to Day 15
Periodo de tiempo: Up to Day 15
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The BP will be evaluated by ABPM for all participants based on the measurement of BP recordings after every 24 hours.
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Up to Day 15
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Placebo Corrected Mean Change From Baseline in Day-time, Night-time, and Hourly SBP and DBP
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Placebo Corrected Mean Change From Baseline in Day-time, Night-time, and Hourly HR
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Placebo Corrected Mean Change From Baseline in Day-time, Night-time, and Hourly MAP and PP
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Number of Participants With Categorical Outliers for SBP and DBP
Periodo de tiempo: Baseline up to Day 15
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Baseline up to Day 15
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Geometric Mean Ratio of Cmax Between the Healthy Japanese and Non-japanese Participants for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Geometric Mean Ratio of AUC Between the Healthy Japanese and Non-japanese Participants for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Geometric Mean Ratio of Cmax Between the Younger Non-japanese (>=18 and <55 years) and older Non-japanese (>=55 to <=85 years) Participants for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Geometric Mean Ratio of AUC Between the Younger Non-japanese (>=18 and <55 years) and older Non-japanese (>=55 to <=85 years) Participants for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Geometric Mean Ratio Between the Non-japanese (>=18 and <55 years) and Elderly Non-japanese (>=65 to <=85 years) Participants for E2511
Periodo de tiempo: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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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)
1 de diciembre de 2021
Finalización primaria (Actual)
18 de agosto de 2022
Finalización del estudio (Actual)
18 de agosto de 2022
Fechas de registro del estudio
Enviado por primera vez
24 de noviembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
24 de noviembre de 2021
Publicado por primera vez (Actual)
7 de diciembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de septiembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- E2511-A001-005
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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 E2511
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Eisai Inc.TerminadoVoluntarios SaludablesEstados Unidos