- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05147337
A Study to Assess the Safety and Tolerability of E2511 in Healthy Adult and Elderly Participants
2022년 9월 8일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
47
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
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California
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Glendale, California, 미국, 91206
- California Clinical Trials Medical Group
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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 정제.
E2511 matched placebo tablets.
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실험적: 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 정제.
E2511 matched placebo tablets.
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실험적: 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 정제.
E2511 matched placebo tablets.
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실험적: 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 정제.
E2511 matched placebo tablets.
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실험적: 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 정제.
E2511 matched placebo tablets.
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실험적: 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 정제.
E2511 matched placebo tablets.
|
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실험적: 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 정제.
E2511 matched placebo tablets.
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실험적: 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 정제.
E2511 matched placebo tablets.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in the Concentration of Acetylcholine (ACh) in Cerebrospinal Fluid (CSF)
기간: Baseline, Day 13
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Baseline, Day 13
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Change From Baseline in Heart Rate (HR)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
|
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
기간: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
|
Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 12월 1일
기본 완료 (실제)
2022년 8월 18일
연구 완료 (실제)
2022년 8월 18일
연구 등록 날짜
최초 제출
2021년 11월 24일
QC 기준을 충족하는 최초 제출
2021년 11월 24일
처음 게시됨 (실제)
2021년 12월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 9월 8일
마지막으로 확인됨
2022년 3월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .