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Healthy VolunteersPhase 1NCT04676685

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 study testing E2730 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, 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… 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?
E2730
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
16 Dec 2020to 23 Jun 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • 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
  • Body mass index (BMI) >=18 and <30 kilograms per meter square (kg/m^2) at Screening

Who cannot join

  • 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
  • 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
Show all 33Show fewer
  • 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
  • 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)
  • 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
  • Any history of gastrointestinal surgery that may affect PK profiles of E2730, example, hepatectomy, nephrectomy, and digestive organ resection
  • 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
  • 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
  • Persistent systolic BP >139 or <90 millimeter of mercury (mmHg) or diastolic BP >89 or <50 mmHg at Screening or Baseline
  • Heart rate <45 beats/minute or >100 beats/minute at Screening or Baseline
  • 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
  • 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)
  • Any current psychiatric symptoms as indicated by a standard screening tool
  • 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)
  • Any lifetime suicidal behavior (per the Suicidal Behavior Section of the C-SSRS)
  • Known history of clinically significant drug allergy at Screening
  • Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
  • Known to be human immunodeficiency virus (HIV) positive at Screening
  • Active viral hepatitis (A, B, or C) and syphilis as demonstrated by positive serology at Screening
  • History of drug or alcohol dependency or abuse, or those who have a positive drug test at Screening or Baseline
  • 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
  • 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
  • Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing
  • Any personal or family history of seizures (including febrile seizures) or 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 (example, history of head concussion, traumatic brain injury, alcohol abuse, substance abuse, developmental abnormalities in the brain)
  • Any epileptiform discharges on resting EEG (including during hyperventilation and photo-stimulation)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Collaborative Neuroscience Research, LLC.

    Long Beach, California, 90806

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose and Single Dose Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy Subjects

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.

Being tested
E2730, E2730-matched placebo
Keywords
E2730, Healthy participants, Pharmacokinetics

What participants receive

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

  • E2730Drug

    E2730 capsules.

  • E2730-matched placeboDrug

    E2730-matched placebo capsules.

Study groups in NCT04676685
Study groupRoleWhat they receive
Part A, Cohort 1: E2730 20 Milligram (mg) or PlaceboExperimentalHealthy Japanese and non-Japanese participants will receive E2730 20 mg or E2730-matched placebo, capsules, orally, once daily for 18 days under fasted conditions.
Receives: Drug: E2730; Drug: E2730-matched placebo
Part A, Cohort 2: E2730 40 mg or PlaceboExperimentalHealthy Japanese and non-Japanese participants will receive E2730 40 mg or E2730-matched placebo, capsules, orally, once daily for 18 days under fasted conditions.
Receives: Drug: E2730; Drug: E2730-matched placebo
Part A, Cohort 3: E2730 60 mg or PlaceboExperimentalHealthy Japanese and non-Japanese participants will receive E2730 60 mg or E2730-matched placebo, capsules, orally, once daily for 18 days under fasted conditions.
Receives: Drug: E2730; Drug: E2730-matched placebo
Part A, Cohort 4: E2730 80 mg or PlaceboExperimentalHealthy Japanese and non-Japanese participants will receive E2730 80 mg or E2730-matched placebo, capsules, orally, once daily for 18 days under fasted conditions.
Receives: Drug: E2730; Drug: E2730-matched placebo
Part B, E2730 80 mg: Fasted + FedExperimentalParticipants 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.
Receives: Drug: E2730
Part B, E2730 80 mg: Fed + FastedExperimentalParticipants 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.
Receives: Drug: E2730

What is being measured

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

  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.

    Measured: Screening up to Day 32 (approximately 60 days)

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

    Measured: Day 1: 0-24 hours; Day 18: 0-336 hours

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

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

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 18: 0-336 hours

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

    Measured: Day 18: 0-24 hours

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

    Measured: 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

    Measured: Day 18: 0-336 hours

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

    Measured: Day 18: 0-336 hours

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 1: 0-288 hours; Day 22: 0-288 hours

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 1: 0-288 hours; Day 22: 0-288 hours

Secondary outcomes (11)

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

    Measured: Baseline, Day 32

  2. Change From Baseline in Heart Rate (HR)

    Measured: Baseline, Day 32

  3. Placebo Corrected Change From Baseline in SBP and DBP

    Measured: Baseline, Day 32

  4. Placebo Corrected Change From Baseline in HR

    Measured: Baseline, Day 32

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

    Measured: Baseline up to Day 32

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

    Measured: Baseline, Day 32

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

    Measured: Baseline, Day 32

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

    Measured: Baseline, Day 32

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

    Measured: 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).

    Measured: Baseline up to Day 32

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

    Measured: Baseline up to Day 32

Timeline

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

  1. First posted21 Dec 2020
  2. Study start16 Dec 2020
  3. Primary completion23 Jun 2021
  4. Study completion23 Jun 2021

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04676685
Sponsor's protocol ID
E2730-A001-013
Status last verified
Aug 2021
First submitted
15 Dec 2020
Last updated
26 Aug 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/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E2730 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 3 inclusion and 33 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 26 Aug 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?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Screening up to Day 32 (approximately 60 days)). The study lists 24 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 NCT04676685.

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 26 Aug 2021.

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