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Healthy VolunteersPhase 1NCT06481488

A Study of E2086 in Healthy Adult Participants

A Phase 1 study testing E2086 in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of the study is to evaluate the safety and tolerability following multiple ascending doses of E2086 in healthy adult participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
E2086
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
25 Jun 2024to 13 Dec 2024
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Non-smoking, male or female, aged greater than or equal to (>=) 18 years to less than or equal to (<=) 55 years (>=20 years to <=55 years for Japanese participants) at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing
  • Japanese participants must have been born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their lifestyle or habits, including diet, while living outside of Japan
  • Body mass index (BMI) >=18 to less than (<) 30 kilogram per square meter (kg/m^2) at screening only for Part A
  • Reports regular bedtime, defined as the time the participant attempts to sleep, between 22:00 and midnight
  • Reports regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 and 10:00

Who cannot join

  • Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 international units per liter (IU/L) or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the dose of study drug
  • All females who are of childbearing potential: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
  • Males who have not had a successful vasectomy (confirmed azoospermia) or their female partners do not meet the criteria above (that is, not of childbearing potential) or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation. No sperm donation is allowed during the study period and for 92 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
  • Any history of surgery that may affect pharmacokinetic (PK) profiles of E2086, example, hepatectomy, nephrotomy, digestive organ resection or participants who have a congenital abnormality in metabolism
Show all 20Show fewer
  • 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
  • Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease, sleep disorders) that in the opinion of the investigators could affect the participant's safety or interfere with the study assessments
  • A prolonged QT/QTc interval (QTcF greater than [>] 450 milliseconds [ms]) demonstrated on ECG at screening or baseline (based on average of triplicate ECGs). A history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QT/QTc interval
  • Left bundle branch block at screening or baseline
  • Persistent systolic blood pressure (BP) >130 or <100 millimeters of mercury (mmHg) or diastolic BP >85 or <50 mmHg at screening or baseline (based on BP measured on at least 3 occasions over 2 weeks)
  • Persistent heart rate (HR) <50 bpm or >100 bpm at screening or baseline (based on HR measured on at least 3 occasions over 2 weeks)
  • History of myocardial infarction, ischemic heart disease, or cardiac failure
  • 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 (including but not limited to depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, anxiety disorders)
  • Any current psychiatric symptoms as indicated by a standard screening tool (Diagnostic and Statistical Manual of Mental Disorders Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult)
  • Participants with 1 or more first degree (blood) relatives who have lifetime diagnosis of bipolar type I disorder or a psychotic disorder
  • Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing
  • History of formally diagnosed moderate to severe obstructive sleep apnea, current use of continuous positive airway pressure, or symptomatic restless legs syndrome

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parexel International

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Combined Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Single Dose Study to Assess Food Effect of E2086 in Healthy Adult Subjects

The primary purpose of the study is to evaluate the safety and tolerability following multiple ascending doses of E2086 in healthy adult participants.

Being tested
E2086, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E2086Drug

    E2086 tablets.

  • PlaceboDrug

    E2086 matched placebo tablets.

Study groups in NCT06481488
Study groupRoleWhat they receive
Part A, Cohort 1: E2086 Dose 1 or PlaceboExperimentalHealthy participants will receive E2086 Dose 1 or two E2086 matched placebo, tablets, orally, once daily after an overnight fast of 10 hours.
Receives: Drug: E2086; Drug: Placebo
Part A, Cohort 2: E2086 Dose 2 or PlaceboExperimentalHealthy participants will receive E2086 Dose 2 or one E2086 matched placebo, tablets, orally, once daily after an overnight fast of 10 hours.
Receives: Drug: E2086; Drug: Placebo
Part A, Cohort 3: E2086 Dose 3 or PlaceboExperimentalHealthy participants will receive E2086 Dose 3 or two E2086 matched placebo, tablets, orally, once daily after an overnight fast of 10 hours.
Receives: Drug: E2086; Drug: Placebo
Part B: E2086 Dose 2 Fasted + E2086 Dose 2 FedExperimentalHealthy participants will receive E2086 Dose 2, tablets, orally, once on Day 1 of Treatment Period 1 in fasted state, followed by E2086 Dose 2, tablets, orally, once on Day 4 of Treatment Period 2 in fed state.
Receives: Drug: E2086
Part B: E2086 Dose 2 Fed + E2086 Dose 2 FastedExperimentalHealthy participants will receive E2086 Dose 2, tablets, orally, once on Day 1 of Treatment Period 1 in fed state, followed by E2086 Dose 2, tablets, orally, once on Day 4 of Treatment Period 2 in fasted state.
Receives: Drug: E2086

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: Day 10

  2. Part A: Number of Participants With Serious Adverse Events (SAEs)

    Measured: Day 10

  3. Part A: Number of Participants With Clinically Significant Abnormal Laboratory Parameters

    Measured: Day 10

  4. Part A: Number of Participants With Clinically Significant Abnormal Vital Signs Values

    Measured: Day 10

  5. Part A: Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings

    Measured: Day 10

  6. Part A: Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings

    Measured: Day 8

  7. Part A: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)

    The C-SSRS 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: Day 10

  8. Part B: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS

    The C-SSRS 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: Day 7

Secondary outcomes (19)

  1. Part A, Cmax: Maximum Observed Plasma Concentration of E2086 and its Metabolite M1

    Measured: Day 1 and at steady-state

  2. Part A, Tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) of E2086 and its Metabolite M1

    Measured: Day 1 and at steady-state

  3. Part A, Css: Average Steady State Concentration of E2086 and its Metabolite M1

    Measured: Day 1 and at steady-state

  4. Part A, AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-dose of E2086 and its Metabolite M1

    Measured: Day 1

  5. Part A, t1/2: Terminal Elimination Phase Half-life of E2086 and its Metabolite M1

    Measured: Day 1 and at steady-state

  6. Part A, Rac (Cmax): Accumulation Ratio for Cmax of E2086 and its Metabolite M1

    Measured: Day 1 and at steady-state

  7. Part A, Rac (AUC0-24h): Accumulation Ratio for AUC0-24 Hours of E2086 and its Metabolite M1

    Measured: Day 1

  8. Part A, Ae: Cumulative Amount of E2086 and its Metabolite M1 Excreted in Urine

    Measured: At steady-state

  9. Part A, CLR: Renal Clearance of E2086 and its Metabolite M1

    Measured: At steady-state

  10. Part A, Fe: Fraction of E2086 and its Metabolite M1 Excreted in Urine

    Measured: At steady-state

  11. Part A, MRU: Ratio of Cumulative Amount of Metabolite M1 to E2086 Excreted in Urine Concentration

    Measured: At steady-state

  12. Part A: Geometric Mean Ratio of Cmax Between Healthy Non-Japanese and Japanese Participants After Administration of E2086

    Measured: Day 1 and at steady-state

  13. Part A: Geometric Mean Ratio of AUC0-24 Hour Between Healthy Non-Japanese and Japanese Participants After Administration of E2086

    Measured: Day 1

  14. Part B: Geometric Mean Ratio of Cmax Between the Fasted and Fed State for Single Dose of E2086 Dose 2

    Measured: After single doses in Fasted and Fed State

  15. Part B: Geometric Mean Ratio of Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Between the Fasted and Fed State for Single Dose of E2086 Dose 2

    Measured: After single doses in Fasted and Fed State

  16. Part B: Geometric Mean Ratio of Area Under the Plasma Concentration-time Curve From Time Zero to Infinite (AUC0-inf) Between the Fasted and Fed State for Single Dose of E2086 Dose 2

    Measured: After single doses in Fasted and Fed State

  17. Part A: Change From Baseline in QTc Using the Fridericia Formula (QTcF) From Holter ECG

    A central ECG laboratory will extract ECG recordings from the Holter device.

    Measured: Baseline to Day 8

  18. Part A: Placebo Corrected Change From Baseline in QTcF Using Holter ECG

    A central ECG laboratory will extract ECG recordings from the Holter device.

    Measured: Baseline to Day 8

  19. Part A: Change From Baseline in Subjective Sleep Onset Latency (sSOL)

    sSOL is a participant-reported parameter. Sleep onset latency is a measure of how long it takes for the participant to fall asleep once the participant gets into bed. This will be measured in minutes.

    Measured: Baseline to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start25 Jun 2024
  3. Primary completion13 Dec 2024
  4. Study completion13 Dec 2024

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part A is a parallel design and Part B is a crossover design.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06481488
Sponsor's protocol ID
E2086-A001-002
Status last verified
Jan 2025
First submitted
25 Jun 2024
Last updated
16 Jan 2025
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/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E2086 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 5 inclusion and 20 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 16 Jan 2025. 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?

Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Day 10). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06481488.

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 16 Jan 2025.

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