Healthy VolunteersPhase 1NCT05147337
A Study to Assess the Safety and Tolerability of E2511 in Healthy Adult and Elderly Participants
A Phase 1 study testing E2511 in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- E2511
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 18 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group
Glendale, California, 91206
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- E2511, Placebo
- Keywords
- E2511, Healthy Participants, Elderly Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2511Drug
E2511 tablets.
PlaceboDrug
E2511 matched placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: E2511 10 mg or Placebo | Experimental | 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. Receives: Drug: E2511; Drug: Placebo |
| Cohort 2: E2511 20 mg or Placebo | Experimental | Non-Japanese adult participants will receive 20 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. Receives: Drug: E2511; Drug: Placebo |
| Cohort 3: E2511 40 mg or Placebo | Experimental | Non-Japanese adult participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. Receives: Drug: E2511; Drug: Placebo |
| Cohort 4: E2511 80 mg or Placebo | Experimental | Non-Japanese adult participants will receive 80 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. Receives: Drug: E2511; Drug: Placebo |
| Cohort 5: E2511 20 mg or Placebo | Experimental | 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. Receives: Drug: E2511; Drug: Placebo |
| Cohort 6: E2511 40 mg or Placebo | Experimental | Japanese adult participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. Receives: Drug: E2511; Drug: Placebo |
| Cohort 7: E2511 80 mg or Placebo | Experimental | Japanese adult participants will receive 80 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. Receives: Drug: E2511; Drug: Placebo |
| Cohort 8: E2511 40 mg or Placebo | Experimental | 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. Receives: Drug: E2511; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Serious Adverse Events (SAEs)
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Laboratory Values
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Vital Signs Values
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Ambulatory Blood Pressure
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)
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.
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Neurological Examination Findings
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings
Measured: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Cmax: Maximum Observed Plasma Concentration for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose
Css,max: Maximum Observed Plasma Concentration at Steady State for E2511
Measured: Day 14: pre-dose up to 24 hours post-dose
tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose
tss,max: Time to Reach Maximum Observed Plasma Concentration (Cmax) at Steady State for E2511
Measured: Day 14: pre-dose up to 24 hours post-dose
Css,av: Average Steady State Plasma Concentration for E2511
Measured: Day 14: pre-dose up to 24 hours post-dose
AUC(0-t): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
t1/2: Terminal Elimination Phase Half-life for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
PTF: Peak-trough Fluctuation for E2511
Measured: Day 14: pre-dose up to 24 hours post-dose
CL/F: Apparent Total Clearance for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose
CLss/F: Apparent Total Clearance at Steady State for E2511
Measured: Day 14: pre-dose up to 24 hours post-dose
Vz/F: Apparent Volume of Distribution at Terminal Phase for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Rac: Accumulation Ratio for E2511 Based on Cmax and AUC
Measured: Day 14: pre-dose up to 24 hours post-dose
Rss: Accumulation Ratio for E2511 Based on Time and Concentration
Measured: Day 14: pre-dose up to 24 hours post-dose
Secondary outcomes (21)
Change From Baseline in the Concentration of Acetylcholine (ACh) in Cerebrospinal Fluid (CSF)
Measured: Baseline, Day 13
Change From Baseline in Heart Rate (HR)
Measured: Baseline up to Day 15
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
Measured: Baseline up to Day 15
Placebo Corrected Change From Baseline in HR
Measured: Baseline up to Day 15
Placebo Corrected Change From Baseline in PR, QRS, and QTc Interval
Measured: Baseline up to Day 15
Number of Participants With Categorical Outliers for HR, PR, QRS and QTc Interval
Measured: Baseline up to Day 15
Number of Participants With Treatment-emergent T-wave and U-wave abnormalities
Measured: Baseline up to Day 15
Mean Change From Baseline in 24-hours Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) up to Day 15
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.
Measured: Up to Day 15
Mean Change From Baseline in Day-time, Night-time, and Hourly SBP and DBP
Measured: Baseline up to Day 15
Mean Change From Baseline in Day-time, Night-time, and Hourly HR
Measured: Baseline up to Day 15
Mean Change From Baseline in Day-time, Night-time, and Hourly Mean Arterial Pressure (MAP) and Pulse Pressure (PP)
Measured: Baseline up to Day 15
Placebo Corrected Mean Change From Baseline in 24-hours SBP and DBP up to Day 15
The BP will be evaluated by ABPM for all participants based on the measurement of BP recordings after every 24 hours.
Measured: Up to Day 15
Placebo Corrected Mean Change From Baseline in Day-time, Night-time, and Hourly SBP and DBP
Measured: Baseline up to Day 15
Placebo Corrected Mean Change From Baseline in Day-time, Night-time, and Hourly HR
Measured: Baseline up to Day 15
Placebo Corrected Mean Change From Baseline in Day-time, Night-time, and Hourly MAP and PP
Measured: Baseline up to Day 15
Number of Participants With Categorical Outliers for SBP and DBP
Measured: Baseline up to Day 15
Geometric Mean Ratio of Cmax Between the Healthy Japanese and Non-japanese Participants for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Geometric Mean Ratio of AUC Between the Healthy Japanese and Non-japanese Participants for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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
Measured: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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
Measured: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Geometric Mean Ratio Between the Non-japanese (>=18 and <55 years) and Elderly Non-japanese (>=65 to <=85 years) Participants for E2511
Measured: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Dec 2021
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147337
- Sponsor's protocol ID
- E2511-A001-005
- Status last verified
- Mar 2022
- First submitted
- 24 Nov 2021
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05147337
- Acronym / sponsor ID
- E2511-A001-005
- Conditions
- Healthy Volunteers
- Keywords
- E2511, Healthy Participants, Elderly Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: E2511 10 mg or Placebo | Experimental | Drug: E2511, Drug: PlaceboNon-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. |
| Cohort 2: E2511 20 mg or Placebo | Experimental | Drug: E2511, Drug: PlaceboNon-Japanese adult participants will receive 20 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. |
| Cohort 3: E2511 40 mg or Placebo | Experimental | Drug: E2511, Drug: PlaceboNon-Japanese adult participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. |
| Cohort 4: E2511 80 mg or Placebo | Experimental | Drug: E2511, Drug: PlaceboNon-Japanese adult participants will receive 80 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. |
| Cohort 5: E2511 20 mg or Placebo | Experimental | Drug: E2511, Drug: PlaceboJapanese 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. |
| Cohort 6: E2511 40 mg or Placebo | Experimental | Drug: E2511, Drug: PlaceboJapanese adult participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. |
| Cohort 7: E2511 80 mg or Placebo | Experimental | Drug: E2511, Drug: PlaceboJapanese adult participants will receive 80 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14. |
| Cohort 8: E2511 40 mg or Placebo | Experimental | Drug: E2511, Drug: PlaceboNon-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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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
Key exclusion criteria (18 listed)
- Females who are breastfeeding or pregnant at Screening or Baseline
- Females of childbearing potential who:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E2511E2511 tablets. | Drug | Cohort 1: E2511 10 mg or Placebo, Cohort 2: E2511 20 mg or Placebo, Cohort 3: E2511 40 mg or Placebo, Cohort 4: E2511 80 mg or Placebo, Cohort 5: E2511 20 mg or Placebo, Cohort 6: E2511 40 mg or Placebo, Cohort 7: E2511 80 mg or Placebo, Cohort 8: E2511 40 mg or Placebo |
| PlaceboE2511 matched placebo tablets. | Drug | Cohort 1: E2511 10 mg or Placebo, Cohort 2: E2511 20 mg or Placebo, Cohort 3: E2511 40 mg or Placebo, Cohort 4: E2511 80 mg or Placebo, Cohort 5: E2511 20 mg or Placebo, Cohort 6: E2511 40 mg or Placebo, Cohort 7: E2511 80 mg or Placebo, Cohort 8: E2511 40 mg or Placebo |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Vital Signs Values
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Ambulatory Blood Pressure
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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.
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Neurological Examination Findings
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Cmax: Maximum Observed Plasma Concentration for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose
Css,max: Maximum Observed Plasma Concentration at Steady State for E2511
Time frame: Day 14: pre-dose up to 24 hours post-dose
tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose
tss,max: Time to Reach Maximum Observed Plasma Concentration (Cmax) at Steady State for E2511
Time frame: Day 14: pre-dose up to 24 hours post-dose
Css,av: Average Steady State Plasma Concentration for E2511
Time frame: Day 14: pre-dose up to 24 hours post-dose
AUC(0-t): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
t1/2: Terminal Elimination Phase Half-life for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
PTF: Peak-trough Fluctuation for E2511
Time frame: Day 14: pre-dose up to 24 hours post-dose
CL/F: Apparent Total Clearance for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose
CLss/F: Apparent Total Clearance at Steady State for E2511
Time frame: Day 14: pre-dose up to 24 hours post-dose
Vz/F: Apparent Volume of Distribution at Terminal Phase for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Rac: Accumulation Ratio for E2511 Based on Cmax and AUC
Time frame: Day 14: pre-dose up to 24 hours post-dose
Rss: Accumulation Ratio for E2511 Based on Time and Concentration
Time frame: Day 14: pre-dose up to 24 hours post-dose
21 secondary outcomes
Change From Baseline in the Concentration of Acetylcholine (ACh) in Cerebrospinal Fluid (CSF)
Time frame: Baseline, Day 13
Change From Baseline in Heart Rate (HR)
Time frame: Baseline up to Day 15
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
Time frame: Baseline up to Day 15
Placebo Corrected Change From Baseline in HR
Time frame: Baseline up to Day 15
Placebo Corrected Change From Baseline in PR, QRS, and QTc Interval
Time frame: Baseline up to Day 15
Number of Participants With Categorical Outliers for HR, PR, QRS and QTc Interval
Time frame: Baseline up to Day 15
Number of Participants With Treatment-emergent T-wave and U-wave abnormalities
Time frame: Baseline up to Day 15
Mean Change From Baseline in 24-hours Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) up to Day 15
Time frame: Up to Day 15
Mean Change From Baseline in Day-time, Night-time, and Hourly SBP and DBP
Time frame: Baseline up to Day 15
Mean Change From Baseline in Day-time, Night-time, and Hourly HR
Time frame: Baseline up to Day 15
Mean Change From Baseline in Day-time, Night-time, and Hourly Mean Arterial Pressure (MAP) and Pulse Pressure (PP)
Time frame: Baseline up to Day 15
Placebo Corrected Mean Change From Baseline in 24-hours SBP and DBP up to Day 15
Time frame: Up to Day 15
Placebo Corrected Mean Change From Baseline in Day-time, Night-time, and Hourly SBP and DBP
Time frame: Baseline up to Day 15
Placebo Corrected Mean Change From Baseline in Day-time, Night-time, and Hourly HR
Time frame: Baseline up to Day 15
Placebo Corrected Mean Change From Baseline in Day-time, Night-time, and Hourly MAP and PP
Time frame: Baseline up to Day 15
Number of Participants With Categorical Outliers for SBP and DBP
Time frame: Baseline up to Day 15
Geometric Mean Ratio of Cmax Between the Healthy Japanese and Non-japanese Participants for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Geometric Mean Ratio of AUC Between the Healthy Japanese and Non-japanese Participants for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
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
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Geometric Mean Ratio Between the Non-japanese (>=18 and <55 years) and Elderly Non-japanese (>=65 to <=85 years) Participants for E2511
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E2511 in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.