CClinicalTrials.gg
Sign In
CompletedNCT04547361Updated Jul 12, 2021

A Study to Assess the Safety and Tolerability of E2511 in Healthy Participants

A Phase 1 interventional study of E2511 and E2511 Matched Placebo in Healthy Volunteers, sponsored by Eisai Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-12.

Sponsored by Eisai Inc. · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was May 2021, 5 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and elderly participants.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • E2511
  • Healthy Participants
03

In context

Lead sponsor

Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Non-smoking, age greater than or equal to (>=) 18 years and less than (\<) 55 years old adult male or female (Cohorts 1 - 6) or age >=65 years and less than or equal to (\<=) 85 years old elderly male or female (Cohort 7) at the time of informed consent
  2. Weight of at least 50 kilogram (kg) and body mass index >=18 and \<30 kilogram per square meter (kg/m\^2) at Screening

Exclusion criteria

Exclusion Criteria:

  1. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria (that is, not of childbearing potential or practicing highly effective contraception throughout the study period plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period plus 90 days after discharge from the study.
  2. Females who are breastfeeding or pregnant at Screening or Baseline

  3. 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 (as described above) throughout the entire study period and for 28 days after study drug discontinuation.
  4. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
  5. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing
  6. Evidence of disease related to chronic headaches, migraines, joint pain or other disorders or disease resulting in chronic or intermittent pain within 4 weeks before dosing
  7. Any personal or family history of seizures (including febrile seizures) or diagnosis of epilepsy or episode of unexplained loss of consciousness
  8. Any history of neurological or other medical conditions which in the opinion of the investigator has the potential to reduce seizure threshold
  9. Any epileptiform discharges in EEG at Screening
  10. A prolonged QT/ QT interval corrected for heart rate (QTc) interval >450 millisecond [ms]) A history of risk factors for torsade de pointes
  11. History of prolonged QT/QTc interval
  12. Left bundle branch block
  13. History of myocardial infarction or active ischemic heart disease
  14. History of clinically significant arrhythmia or uncontrolled arrhythmia
  15. Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the C-SSRS
  16. Any lifetime history of psychiatric disease
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Cohort 1: Dose 1 E2511 or Placebo

    Participants will receive Dose 1 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition.

    Drug: E2511 · Drug: E2511 Matched Placebo

  • Experimental
    Cohort 2: Dose 2 E2511 or Placebo

    Participants will receive Dose 2 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition.

    Drug: E2511 · Drug: E2511 Matched Placebo

  • Experimental
    Cohort 3: Dose 3 E2511 or Placebo

    Participants will receive Dose 3 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 (Treatment Period 1) under fasted condition followed by Dose 3 of E2511 or E2511 matched placebo, tablets, orally, once on Day 7 (Treatment Period 2) under fed condition. A washout period of 6 days will be maintained between the doses.

    Drug: E2511 · Drug: E2511 Matched Placebo

  • Experimental
    Cohort 4: Dose 4 E2511 or Placebo

    Participants will receive Dose 4 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition.

    Drug: E2511 · Drug: E2511 Matched Placebo

  • Experimental
    Cohort 5: Dose 5 E2511 or Placebo

    Participants will receive Dose 5 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition.

    Drug: E2511 · Drug: E2511 Matched Placebo

  • Experimental
    Cohort 6: Dose 6 E2511 or Placebo

    Participants will receive Dose 6 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition.

    Drug: E2511 · Drug: E2511 Matched Placebo

  • Experimental
    Cohort 7: Dose 3 E2511 (Elderly Participants) or Placebo

    Elderly participants will receive Dose 3 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition.

    Drug: E2511 · Drug: E2511 Matched Placebo

Interventions

  • DrugE2511

    E2511 tablets.

  • DrugE2511 Matched Placebo

    Placebo tablets matching E2511 tablets.

06

What researchers measure

Primary outcomes

  1. Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: From screening up to 28 days after last dose of study drug (up to 63 days)

  2. Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Markedly Abnormal Laboratory Values

    Time frame: From screening up to 28 days after last dose of study drug (up to 63 days)

  3. Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Vital Signs Values

    Time frame: From screening up to 28 days after last dose of study drug (up to 63 days)

  4. Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Electrocardiograms (ECGs) Findings

    Time frame: From screening up to 28 days after last dose of study drug (up to 63 days)

  5. Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Treatment-emergent 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.

    Time frame: From screening up to 28 days after last dose of study drug (up to 63 days)

  6. Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Physical Examination Findings

    Time frame: From screening up to 28 days after last dose of study drug (up to 63 days)

  7. Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Neurological Exam Findings

    Time frame: Cohorts 1, 2, 4, 5, 6, 7: Screening up to Day 1 (approximately 28 days); Cohort 3: Screening up to Day 7 (approximately 35 days)

  8. Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Psychiatric Assessment

    Number of participants with clinically significant change in psychiatric assessment will be evaluated by a psychiatrist as a measure of mental health assessment.

    Time frame: From screening up to 28 days after last dose of study drug (up to 63 days)

  9. Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Electroencephalogram (EEG) Measurements

    Time frame: From screening up to Day 2 (approximately 30 days)

  10. Cohorts 1, 2, 3, 4, 5, 6, 7: Maximum Observed Plasma Concentration (Cmax) for E2511 on Day 1

    Time frame: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  11. Cohort 3: Maximum Observed Plasma Concentration (Cmax) for E2511 on Day 7

    Time frame: Day 7: pre-dose up to a potential maximum of 120 hours post-dose

  12. Cohorts 1, 2, 3, 4, 5, 6, 7: Time to Reach Cmax (tmax) for E2511 on Day 1

    Time frame: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  13. Cohort 3: Time to Reach Cmax (tmax) for E2511 on Day 7

    Time frame: Day 7: pre-dose up to a potential maximum of 120 hours post-dose

  14. Cohorts 1, 2, 3, 4, 5, 6, 7: Area Under the Plasma Concentration-time Curve (AUC(0-t)) From Time Zero to the Last Quantifiable Plasma Concentration for E2511 on Day 1

    Time frame: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  15. Cohort 3: Area Under the Plasma Concentration-time Curve (AUC(0-t)) From Time Zero to the Last Quantifiable Plasma Concentration for E2511 on Day 7

    Time frame: Day 7: pre-dose up to a potential maximum of 120 hours post-dose

  16. Cohorts 1, 2, 3, 4, 5, 6, 7: Area Under the Plasma Concentration-time Curve (AUC(0-inf)) From Time Zero to Infinity for E2511 on Day 1

    Time frame: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  17. Cohort 3: Area Under the Plasma Concentration-time Curve (AUC(0-inf)) From Time Zero to Infinity for E2511 on Day 7

    Time frame: Day 7: pre-dose up to a potential maximum of 120 hours post-dose

  18. Cohorts 1, 2, 3, 4, 5, 6, 7: Area Under the Plasma Concentration-time Curve (AUC(0-24)) From Time Zero to 24 Hours Postdose for E2511 on Day 1

    Time frame: Day 1: pre-dose up to a potential maximum of 24 hours post-dose

  19. Cohort 3: Area Under the Plasma Concentration-time Curve (AUC(0-24)) From Time Zero to 24 Hours Postdose for E2511 on Day 7

    Time frame: Day 7: pre-dose up to a potential maximum of 24 hours post-dose

  20. Cohorts 1, 2, 3, 4, 5, 6, 7: Terminal Elimination Phase Half-Life (t1/2) for E2511 on Day 1

    Time frame: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  21. Cohort 3: Terminal Elimination Phase Half-Life (t1/2) for E2511 on Day 7

    Time frame: Day 7: pre-dose up to a potential maximum of 120 hours post-dose

  22. Cohorts 1, 2, 3, 4, 5, 6, 7: Apparent Total Clearance (CL/F) for E2511 on Day 1

    Time frame: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  23. Cohort 3: Apparent Total Clearance (CL/F) for E2511 on Day 7

    Time frame: Day 7: pre-dose up to a potential maximum of 120 hours post-dose

  24. Cohorts 1, 2, 3, 4, 5, 6, 7: Apparent Volume of Distribution at Terminal Phase (Vz/F) for E2511 on Day 1

    Time frame: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  25. Cohort 3: Apparent Volume of Distribution at Terminal Phase (Vz/F) for E2511 on Day 7

    Time frame: Day 7: pre-dose up to a potential maximum of 120 hours post-dose

Secondary outcomes

  1. Cohort 3: Geometric Mean Ratio of Cmax Between the Fasted and Fed State for E2511 20 mg

    Time frame: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose

  2. Cohort 3: Geometric Mean Ratio of AUC(0-t) Between the Fasted and fed State for E2511 20 mg

    Time frame: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose

  3. Cohort 3: Geometric Mean Ratio of AUC(0-inf) Between the Fasted and fed State for E2511 20 mg

    Time frame: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose

  4. Cohort 3 and Cohort 7: Geometric Mean Ratio of Cmax Between the Healthy Elderly and Adult Participants for E2511 20 mg

    Time frame: Cohort 3: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose; Cohort 7: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  5. Cohort 3 and Cohort 7: Geometric Mean Ratio of AUC(0-t) Between the Healthy Elderly and Adult Participants for E2511 20 mg

    Time frame: Cohort 3: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose; Cohort 7: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  6. Cohort 3 and Cohort 7: Geometric Mean Ratio of AUC(0-inf) Between the Healthy Elderly and Adult Participants for E2511 20 mg

    Time frame: Cohort 3: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose; Cohort 7: Day 1: pre-dose up to a potential maximum of 120 hours post-dose

  7. Cohorts 1, 2, 3, 4, 5, 6, 7: Correlation Between QTc and E2511 Plasma Concentrations

    To explore the correlation between changes in QTc interval (msec) and E2511 plasma concentrations, appropriate correction method for QTc interval calculation such as QTcF will used for analysis. Holter monitors will be used to collect continuous 12-lead ECG data, from which high precision ECG recordings will be extracted from the Holter monitor data prior to the PK blood samples collected.

    Time frame: Day 1: Pre-dose through 24 hours post dose

07

Study locations

1 site
  • Worldwide Clinical Trials
    San Antonio, Texas 78217, United States
08

References and documents

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04547361
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Sep 14, 2020
Start date
Sep 14, 2020
Primary completion
May 26, 2021
Completion
May 26, 2021
Last update
Jul 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Eisai Inc.

Start the discussion