Healthy VolunteersPhase 1NCT04547361
A Study to Assess the Safety and Tolerability of E2511 in Healthy 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 pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and elderly 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
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 26 May 2021
- 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, 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
- Weight of at least 50 kilogram (kg) and body mass index >=18 and <30 kilogram per square meter (kg/m^2) at Screening
Who cannot join
- 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.
- 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 (as described above) 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
Show all 18Show fewer
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing
- 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
- 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 epileptiform discharges in EEG at Screening
- A prolonged QT/ QT interval corrected for heart rate (QTc) interval >450 millisecond [ms]) A history of risk factors for torsade de pointes
- History of prolonged QT/QTc interval
- 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.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2511 in Healthy Subjects
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.
- Conditions
- Healthy Volunteers
- Being tested
- E2511, E2511 Matched Placebo
- Keywords
- E2511, Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2511Drug
E2511 tablets.
E2511 Matched PlaceboDrug
Placebo tablets matching E2511 tablets.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose 1 E2511 or Placebo | Experimental | Participants will receive Dose 1 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. Receives: Drug: E2511; Drug: E2511 Matched Placebo |
| Cohort 2: Dose 2 E2511 or Placebo | Experimental | Participants will receive Dose 2 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. Receives: Drug: E2511; Drug: E2511 Matched Placebo |
| Cohort 3: Dose 3 E2511 or Placebo | Experimental | 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. Receives: Drug: E2511; Drug: E2511 Matched Placebo |
| Cohort 4: Dose 4 E2511 or Placebo | Experimental | Participants will receive Dose 4 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. Receives: Drug: E2511; Drug: E2511 Matched Placebo |
| Cohort 5: Dose 5 E2511 or Placebo | Experimental | Participants will receive Dose 5 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. Receives: Drug: E2511; Drug: E2511 Matched Placebo |
| Cohort 6: Dose 6 E2511 or Placebo | Experimental | Participants will receive Dose 6 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. Receives: Drug: E2511; Drug: E2511 Matched Placebo |
| Cohort 7: Dose 3 E2511 (Elderly Participants) or Placebo | Experimental | Elderly participants will receive Dose 3 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. Receives: Drug: E2511; Drug: E2511 Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Markedly Abnormal Laboratory Values
Measured: From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Vital Signs Values
Measured: From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Electrocardiograms (ECGs) Findings
Measured: From screening up to 28 days after last dose of study drug (up to 63 days)
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.
Measured: From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Physical Examination Findings
Measured: From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Neurological Exam Findings
Measured: 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)
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.
Measured: From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Electroencephalogram (EEG) Measurements
Measured: From screening up to Day 2 (approximately 30 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Maximum Observed Plasma Concentration (Cmax) for E2511 on Day 1
Measured: Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Maximum Observed Plasma Concentration (Cmax) for E2511 on Day 7
Measured: Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Time to Reach Cmax (tmax) for E2511 on Day 1
Measured: Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Time to Reach Cmax (tmax) for E2511 on Day 7
Measured: Day 7: pre-dose up to a potential maximum of 120 hours post-dose
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
Measured: Day 1: pre-dose up to a potential maximum of 120 hours post-dose
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
Measured: Day 7: pre-dose up to a potential maximum of 120 hours post-dose
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
Measured: Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Area Under the Plasma Concentration-time Curve (AUC(0-inf)) From Time Zero to Infinity for E2511 on Day 7
Measured: Day 7: pre-dose up to a potential maximum of 120 hours post-dose
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
Measured: Day 1: pre-dose up to a potential maximum of 24 hours post-dose
Cohort 3: Area Under the Plasma Concentration-time Curve (AUC(0-24)) From Time Zero to 24 Hours Postdose for E2511 on Day 7
Measured: Day 7: pre-dose up to a potential maximum of 24 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Terminal Elimination Phase Half-Life (t1/2) for E2511 on Day 1
Measured: Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Terminal Elimination Phase Half-Life (t1/2) for E2511 on Day 7
Measured: Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Apparent Total Clearance (CL/F) for E2511 on Day 1
Measured: Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Apparent Total Clearance (CL/F) for E2511 on Day 7
Measured: Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Apparent Volume of Distribution at Terminal Phase (Vz/F) for E2511 on Day 1
Measured: Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Apparent Volume of Distribution at Terminal Phase (Vz/F) for E2511 on Day 7
Measured: Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Secondary outcomes (7)
Cohort 3: Geometric Mean Ratio of Cmax Between the Fasted and Fed State for E2511 20 mg
Measured: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Geometric Mean Ratio of AUC(0-t) Between the Fasted and fed State for E2511 20 mg
Measured: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Geometric Mean Ratio of AUC(0-inf) Between the Fasted and fed State for E2511 20 mg
Measured: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3 and Cohort 7: Geometric Mean Ratio of Cmax Between the Healthy Elderly and Adult Participants for E2511 20 mg
Measured: 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
Cohort 3 and Cohort 7: Geometric Mean Ratio of AUC(0-t) Between the Healthy Elderly and Adult Participants for E2511 20 mg
Measured: 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
Cohort 3 and Cohort 7: Geometric Mean Ratio of AUC(0-inf) Between the Healthy Elderly and Adult Participants for E2511 20 mg
Measured: 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
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.
Measured: Day 1: Pre-dose through 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 posted14 Sep 2020
- Study start14 Sep 2020
- Primary completion26 May 2021
- Study completion26 May 2021
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
- 45 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
- NCT04547361
- Sponsor's protocol ID
- E2511-A001-004
- Status last verified
- Jan 2021
- First submitted
- 7 Sep 2020
- Last updated
- 12 Jul 2021
- 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 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2511 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04547361
- Acronym / sponsor ID
- E2511-A001-004
- Conditions
- Healthy Volunteers
- Keywords
- E2511, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 14 Sep 2020 (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 pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and elderly participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose 1 E2511 or Placebo | Experimental | Drug: E2511, Drug: E2511 Matched PlaceboParticipants will receive Dose 1 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. |
| Cohort 2: Dose 2 E2511 or Placebo | Experimental | Drug: E2511, Drug: E2511 Matched PlaceboParticipants will receive Dose 2 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. |
| Cohort 3: Dose 3 E2511 or Placebo | Experimental | Drug: E2511, Drug: E2511 Matched PlaceboParticipants 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. |
| Cohort 4: Dose 4 E2511 or Placebo | Experimental | Drug: E2511, Drug: E2511 Matched PlaceboParticipants will receive Dose 4 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. |
| Cohort 5: Dose 5 E2511 or Placebo | Experimental | Drug: E2511, Drug: E2511 Matched PlaceboParticipants will receive Dose 5 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. |
| Cohort 6: Dose 6 E2511 or Placebo | Experimental | Drug: E2511, Drug: E2511 Matched PlaceboParticipants will receive Dose 6 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. |
| Cohort 7: Dose 3 E2511 (Elderly Participants) or Placebo | Experimental | Drug: E2511, Drug: E2511 Matched PlaceboElderly participants will receive Dose 3 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- Weight of at least 50 kilogram (kg) and body mass index >=18 and <30 kilogram per square meter (kg/m^2) at Screening
Key exclusion criteria (18 listed)
- 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.
- 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
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: Dose 1 E2511 or Placebo, Cohort 2: Dose 2 E2511 or Placebo, Cohort 3: Dose 3 E2511 or Placebo, Cohort 4: Dose 4 E2511 or Placebo, Cohort 5: Dose 5 E2511 or Placebo, Cohort 6: Dose 6 E2511 or Placebo, Cohort 7: Dose 3 E2511 (Elderly Participants) or Placebo |
| E2511 Matched PlaceboPlacebo tablets matching E2511 tablets. | Drug | Cohort 1: Dose 1 E2511 or Placebo, Cohort 2: Dose 2 E2511 or Placebo, Cohort 3: Dose 3 E2511 or Placebo, Cohort 4: Dose 4 E2511 or Placebo, Cohort 5: Dose 5 E2511 or Placebo, Cohort 6: Dose 6 E2511 or Placebo, Cohort 7: Dose 3 E2511 (Elderly Participants) or Placebo |
Primary outcome
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)
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)
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)
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)
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)
Time frame: From screening up to 28 days after last dose of study drug (up to 63 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.
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)
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)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Psychiatric Assessment
Time frame: From screening up to 28 days after last dose of study drug (up to 63 days)
Number of participants with clinically significant change in psychiatric assessment will be evaluated by a psychiatrist as a measure of mental health assessment.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
7 secondary outcomes
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
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
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
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
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
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
Cohorts 1, 2, 3, 4, 5, 6, 7: Correlation Between QTc and E2511 Plasma Concentrations
Time frame: Day 1: Pre-dose through 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 12 Jul 2021.
- 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
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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 2 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 12 Jul 2021. 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?
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)). 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 12 Jul 2021.