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CompletedNCT04676685Updated Aug 26, 2021

A Study to Assess the Safety and Tolerability of E2730 After Multiple Dose and the Food Effect After Single Dose in Healthy Participants

A Phase 1 interventional study of E2730 and E2730-matched placebo in Healthy Volunteers, sponsored by Eisai Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-26.

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

From the registry’s dates

  • Primary completion was Jun 2021, 5 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The primary purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E2730 of multiple ascending oral doses in healthy adult participants and to assess the differences in PK, safety, and tolerability of E2730 between healthy Japanese and non-Japanese participants following multiple doses. This study will also determine the effect of food on PK of E2730.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • E2730
  • Healthy participants
  • Pharmacokinetics
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 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Non-smoking, healthy male or female, age greater than or equal to (>=) 18 years and \<55 years old at the time of informed consent. To be considered non-smokers, Participants must have discontinued smoking for at least 4 weeks before dosing
  2. 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 life style or habits, including diet, while living outside of Japan
  3. Body mass index (BMI) >=18 and \<30 kilograms per meter square (kg/m\^2) at Screening

Exclusion criteria

Exclusion Criteria:

  1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug

  2. Females of childbearing potential who:

    • Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
    • Total abstinence (if it is their preferred and usual lifestyle)
    • An intrauterine device or intrauterine hormone-releasing system (IUS)
    • A contraceptive implant
    • An oral contraceptive (Participant must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of the oral contraceptive throughout the study and for 28 days after study drug discontinuation)
    • Have a vasectomized partner with confirmed azoospermia
    • Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation
  3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (that is, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 5 times the half-life of the study drug plus 90 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; 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
  6. Any history of gastrointestinal surgery that may affect PK profiles of E2730, example, hepatectomy, nephrectomy, and digestive organ resection
  7. Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening
  8. A prolonged QT interval of the ECG/Corrected QT interval (QT/QTc) (QTcF greater than [>] 450 milliseconds [ms]) demonstrated by a repeated 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
  9. Persistent systolic BP >139 or \<90 millimeter of mercury (mmHg) or diastolic BP >89 or \<50 mmHg at Screening or Baseline
  10. Heart rate \<45 beats/minute or >100 beats/minute at Screening or Baseline
  11. Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) or equivalent scale or via interview with a psychiatrist
  12. 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 ). The absence of a history of psychiatric disease should be documented by a checklist in the electronic case report form (eCRF)
  13. Any current psychiatric symptoms as indicated by a standard screening tool
  14. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS)
  15. Any lifetime suicidal behavior (per the Suicidal Behavior Section of the C-SSRS)
  16. Known history of clinically significant drug allergy at Screening
  17. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
  18. Known to be human immunodeficiency virus (HIV) positive at Screening
  19. Active viral hepatitis (A, B, or C) and syphilis as demonstrated by positive serology at Screening
  20. History of drug or alcohol dependency or abuse, or those who have a positive drug test at Screening or Baseline
  21. Exposure within the last 14 days to an individual with confirmed or probable corona virus disease 2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention (CDC) list of COVID symptoms or any other reason to consider the participants at potential risk for an acute COVID-19 infection
  22. Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 half-lives, whichever is longer, preceding informed consent
  23. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing
  24. Any personal or family history of seizures (including febrile seizures) or epilepsy or episode of unexplained loss of consciousness
  25. Any history of neurological or other medical conditions which in the opinion of the investigator has the potential to reduce seizure threshold (example, history of head concussion, traumatic brain injury, alcohol abuse, substance abuse, developmental abnormalities in the brain)
  26. Any epileptiform discharges on resting EEG (including during hyperventilation and photo-stimulation)
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Part A, Cohort 1: E2730 20 Milligram (mg) or Placebo

    Healthy Japanese and non-Japanese participants will receive E2730 20 mg or E2730-matched placebo, capsules, orally, once daily for 18 days under fasted conditions.

    Drug: E2730 · Drug: E2730-matched placebo

  • Experimental
    Part A, Cohort 2: E2730 40 mg or Placebo

    Healthy Japanese and non-Japanese participants will receive E2730 40 mg or E2730-matched placebo, capsules, orally, once daily for 18 days under fasted conditions.

    Drug: E2730 · Drug: E2730-matched placebo

  • Experimental
    Part A, Cohort 3: E2730 60 mg or Placebo

    Healthy Japanese and non-Japanese participants will receive E2730 60 mg or E2730-matched placebo, capsules, orally, once daily for 18 days under fasted conditions.

    Drug: E2730 · Drug: E2730-matched placebo

  • Experimental
    Part A, Cohort 4: E2730 80 mg or Placebo

    Healthy Japanese and non-Japanese participants will receive E2730 80 mg or E2730-matched placebo, capsules, orally, once daily for 18 days under fasted conditions.

    Drug: E2730 · Drug: E2730-matched placebo

  • Experimental
    Part B, E2730 80 mg: Fasted + Fed

    Participants will receive a single treatment of E2730 (80 mg capsule) in fasted condition on Day 1 treatment period 1 followed by E2730 80 mg capsule in fed condition on Day 1 of treatment period 2. A washout period of at least 21 days will be maintained between the 2 treatments.

    Drug: E2730

  • Experimental
    Part B, E2730 80 mg: Fed + Fasted

    Participants will receive a single treatment of E2730 80 mg capsule in fed condition on Day 1 of treatment period 1 followed by E2730 80 mg capsule in fasted condition on Day 1 of treatment period 2. A washout period of at least 21 days will be maintained between the 2 treatments.

    Drug: E2730

Interventions

  • DrugE2730

    E2730 capsules.

  • DrugE2730-matched placebo

    E2730-matched placebo capsules.

06

What researchers measure

Primary outcomes

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

    Safety assessments will consist of monitoring and recording all adverse events (AEs); laboratory evaluation for hematology, clinical chemistry, and urinalysis; periodic measurement of vital signs, electrocardiograms (ECGs), electroencephalogram (EEGs), corrected QT (QTc) interval and blood pressure.

    Time frame: Screening up to Day 32 (approximately 60 days)

  2. Part A, Cmax: Maximum Observed Plasma Concentration for E2730

    Time frame: Day 1: 0-24 hours; Day 18: 0-336 hours

  3. Part A, Css,min: Minimum Observed Plasma Concentration at Steady State for E2730

    Time frame: Time Frame: Day 18: 0-24 hours

  4. Part A, tmax: Time at Which the Highest Drug Plasma Concentration Occurs for E2730

    Time frame: Day 1: 0-24 hours; Day 18: 0-336 hours

  5. Part A, Css,av: Average Steady State Plasma Concentration at Steady State for E2730

    Time frame: Time Frame: Day 18: 0-24 hours

  6. Part A, AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours After Dosing for E2730

    Time frame: Day 1: 0-24 hours; Day 18: 0-24 hours

  7. Part A, t1/2: Terminal Elimination Phase Half-life Following Last day of Dosing for E2730

    Time frame: Day 18: 0-336 hours

  8. Part A, PTF: Peak-trough Fluctuation for E2730

    Time frame: Day 18: 0-24 hours

  9. Part A, Rac: Accumulation Ratio for Cmax and AUC for E2730

    Time frame: Day 1: 0-24 hours; Day 18: 0-24 hours

  10. Part A, CLss/F: Apparent Total Clearance Following Extravascular Administration at Steady State for E2730

    Time frame: Day 18: 0-336 hours

  11. Part A, Vz/F: Apparent Volume of Distribution at Terminal Phase

    Time frame: Day 18: 0-336 hours

  12. Part B, Cmax: Maximum Observed Plasma Concentration for E2730

    Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours

  13. Part B, tmax: Time at Which the Highest Drug Plasma Concentration Occurs for E2730

    Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours

  14. Part B, AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours After Dosing for E2730

    Time frame: Day 1: 0-24 hours; Day 22: 0-24 hours

  15. Part B, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E2730

    Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours

  16. Part B, AUC(0-72h): Area Under the Plasma Concentration-time Curve From Zero Time to 72 Hours After Dosing for E2730

    Time frame: Day 1: 0-72 hours; Day 22: 0-72 hours

  17. Part B, AUC(0-inf): Area Under the Plasma Concentration-time Curve From Zero Time Extrapolated to Infinite Time for E2730

    Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours

  18. Part B, t1/2: Terminal Elimination Phase Half-life for E2730

    Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours

  19. Part A: Geometric Mean Ratio of Cmax Between the Healthy Japanese and non-Japanese Participants for E2730

    Time frame: Day 1: 0-24 hours; Day 18: 0-336 hours

  20. Part A: Geometric Mean Ratio of AUC(0-24) Between the Healthy Japanese and non-Japanese Participants for E2730

    Time frame: Day 1: 0-24 hours; Day 18: 0-24 hours

  21. Part B: Geometric Mean Ratio of Cmax Between the Fasted and fed State for E2730

    Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours

  22. Part B: Geometric Mean Ratio of AUC(0-t) Between the Fasted and fed State for E2730

    Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours

  23. Part B: Geometric Mean Ratio of AUC(0-72h) Between the Fasted and fed State for E2730

    Time frame: Day 1: 0-72 hours; Day 22: 0-72 hours

  24. Part B: Geometric Mean Ratio of AUC(0-inf) Between the Fasted and fed State for E2730

    Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours

Secondary outcomes

  1. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Day 32

  2. Change From Baseline in Heart Rate (HR)

    Time frame: Baseline, Day 32

  3. Placebo Corrected Change From Baseline in SBP and DBP

    Time frame: Baseline, Day 32

  4. Placebo Corrected Change From Baseline in HR

    Time frame: Baseline, Day 32

  5. Number of Participants With Categorical Outliers for SBP and DBP

    Time frame: Baseline up to Day 32

  6. Change From Baseline in QT Interval by Fridericia (QTcF)

    Time frame: Baseline, Day 32

  7. Change From Baseline in PR Interval of the ECG (PR), QRS Interval of the ECG (QRS)

    Time frame: Baseline, Day 32

  8. Placebo Corrected Change From Baseline in QTcF, PR and QRS

    Time frame: Baseline, Day 32

  9. Number of Participants With Categorical Outliers for QTcF, HR, PR, and QRS

    Time frame: Baseline, Day 32

  10. Number of Participants With T-wave Morphology Changes

    The T-wave morphology categories includes the following: Normal T-wave (Any positive T-wave not meeting any criterion); Flat T-wave (T amplitude less than (\<) 1 millimeter \[mm\] \[either positive or negative\] including flat isoelectric line); Notched T-wave (+) (Presence of notch(es) of at least 0.05 millivolt \[mV\] amplitude on ascending or descending arm of the positive T-wave); Biphasic (T-wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T-waves included); Normal T-wave (-) (T amplitude that is negative, without biphasic T-wave or notches); Notched T-wave (-) (Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T-wave).

    Time frame: Baseline up to Day 32

  11. Number of Participants With Presence of Abnormal U-wave

    Time frame: Baseline up to Day 32

07

Study locations

1 site
  • Collaborative Neuroscience Research, LLC.
    Long Beach, California 90806, 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 Aug 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04676685
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Dec 21, 2020
Start date
Dec 16, 2020
Primary completion
Jun 23, 2021
Completion
Jun 23, 2021
Last update
Aug 26, 2021

Oversight

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

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