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Healthy VolunteersPhase 1NCT07766369

A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants

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

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary purpose of this study is to assess potential drug-drug interactions of E2086 when coadministered orally with Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, or Combined Oral Contraceptives in Healthy 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?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteUnited States
Study dates
12 Aug 2026to 12 Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Body Mass Index (BMI) greater than or equal to (≥) 18 and less than (<) 30 kilograms per square meter (kg/m2) at Screening
  • Non-smoking and non-vaping, healthy male or female, age ≥18 years and ≤55 years old at the time of informed consent (only Parts A and B).
  • Non-smoking and non-vaping, healthy female, age ≥18 years and ≤55 years old at the time of informed consent (only Part C).

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 first dose of study drug
  • Females of childbearing potential who did not use a highly effective method of contraception (as described below) within 28 days before study entry, or who do not agree to use an approved method of contraception from 28 days before study entry throughout the entire study period, and for 28 days after study drug discontinuation.
  • Approved (highly effective) methods of contraception for this study include at least 1 of the following:
  • Total abstinence (if it is her preferred and usual lifestyle)
  • Have a vasectomized partner with confirmed azoospermia
  • Double-barrier method (such as condom plus diaphragm with spermicide) NOTE: All females will be considered 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 (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
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  • Subjects who are using steroidal hormones including for contraceptives, implants and intrauterine system, or for any other indications from 4 weeks before informed consent until study discharge from the final period
  • 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; eg, 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 pharmacokinetics (PK) profiles of E2086 (eg, hepatectomy, nephrectomy, digestive organ resection) or subjects who have a congenital abnormality in metabolism at Screening
  • Any clinically abnormal symptom or organ impairment found by medical history at Screening, including estimated glomerular filtration rate (eGFR) <90 milliliters per minute (ml/min), and physical examinations, vital signs, ECG findings, or laboratory test results that require medical treatment at Screening or Baseline
  • A prolonged QT/corrected (QTc) interval (QT interval corrected for heart rate using Fridericia's formula [QTcF] >450 millisecond [ms]) as demonstrated by the mean of triplicate ECGs (recorded at least 1 minute [min] apart) at Screening or Baseline
  • Systolic blood pressure >140 millimeters of mercury (mmHg) or diastolic blood pressure >90 mmHg at Screening or Baseline
  • Heart rate <50 beats per (/) min or >100 beats/min 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).
  • Any lifetime history of psychiatric disease (including, but not limited to, depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, and anxiety disorders [if ever treated with medication]).
  • 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
  • History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline.
  • 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
  • Use of illegal recreational drugs and marijuana
  • Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing.
  • A history of noncompliance in any previous study or inability to comply with study conduct, as assessed by the investigator
  • Any other findings that the investigator feels would increase the risk of having an adverse outcome from participating in the study
  • Subjects carrying human leukocyte antigen (HLA)-B*1502 or HLA-A*3101 (only Part A -CBZ treatment group)
  • Genetically determined poor metabolizers of CYP2D6 substrates (only Part B - MDZ, DEX, and BUP)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eisai Medical Information contact

+1-888-274-2378

esi_medinfo@eisai.com

United States1 site, 1 recruiting

  • PPD Austin Clinical Research Unit (CRU)- Phase 1

    Austin, Texas, 78744

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1, Open-label, 3-Part Study to Assess Potential Drug-Drug Interactions of E2086 When Coadministered Orally With Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, or Combined Oral Contraceptives in Healthy Subjects

The primary purpose of this study is to assess potential drug-drug interactions of E2086 when coadministered orally with Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, or Combined Oral Contraceptives in Healthy Participants

Being tested
E2086

What participants receive

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

  • E2086Drug

    Specified dose on specified days

Study groups in NCT07766369
Study groupRoleWhat they receive
Part A: E2086 + ItraconazoleExperimentalOral doses of E2086 in healthy male and female participants dosed alone or in combination with itraconazole at steady state
Receives: Drug: E2086
Part A: E2086 + CarbamazepineExperimentalOral doses of E2086 in healthy male and female participants dosed alone or in combination with carbamazepine at steady state
Receives: Drug: E2086
Part B: E2086 + Midazolam + Dextromethorphan + BupropionExperimentalOral doses of midazolam, dextromethorphan, and bupropion in healthy male and female participants dosed alone or in combination with E2086 at steady state
Receives: Drug: E2086
Part C: E2086 + Ethinyl estradiol + NorethindroneExperimentalSingle dose combined oral contraceptive (ethinyl estradiol and norethindrone) healthy female participants dosed alone or in combination with E2086 at steady state
Receives: Drug: E2086

What is being measured

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

  1. Part A, area under concentration versus time curve from zero time (predose) to time of last quantifiable concentration AUC(0-t) of E2086 and its Metabolite M1

    Measured: Day 1 to Day 4; Day 7 to Day 13

  2. Part A, area under concentration versus time curve from zero time (predose) to infinite time AUC(0-inf) of E2086 and its Metabolite M1

    Measured: Day 1 to Day 4; Day 7 to Day 13

  3. Part A, maximum observed concentration (Cmax) of E2086 and its Metabolite M1

    Measured: Day 1; Day 7

  4. Part B, AUC(0-t) of midazolam (MDZ)

    Measured: Day 1 to Day 4; Day 15 to Day 18

  5. Part B, AUC(0-t) of dextromethorphan (DEX)

    Measured: Day 1 to Day 4; Day 15 to Day 18

  6. Part B, AUC(0-t) of bupropion (BUP)

    Measured: Day 4 to Day 8; Day 18 to Day 22

  7. Part B, AUC(0-t) of hydroxybupropion

    Measured: Day 4 to Day 8; Day 18 to Day 22

  8. Part B, AUC(0-inf) of MDZ

    Measured: Day 1 to Day 4; Day 15 to Day 18

  9. Part B, AUC(0-inf) of DEX

    Measured: Day 1 to Day 4; Day 15 to Day 18

  10. Part B, AUC(0-inf) of BUP

    Measured: Day 4 to Day 8; Day 18 to Day 22

  11. Part B, AUC(0-inf) of hydroxybupropion

    Measured: Day 4 to Day 8; Day 18 to Day 22

  12. Part B, Cmax of MDZ

    Measured: Day 1 and Day 15

  13. Part B, Cmax of DEX

    Measured: Day 1 and Day 15

  14. Part B, Cmax of BUP

    Measured: Day 4 and Day 18

  15. Part B, Cmax of hydroxybupropion

    Measured: Day 4 and Day 18

  16. Part C, AUC(0-t) of ethinyl estradiol (EE)

    Measured: Day 1 to Day 5; Day 12 to Day 16

  17. Part C, AUC(0-t) of norethindrone (NET)

    Measured: Day 1 to Day 5; Day 12 to Day 16

  18. Part C, AUC(0-inf) of EE

    Measured: Day 1 to Day 5; Day 12 to Day 16

  19. Part C, AUC(0-inf) of NET

    Measured: Day 1 to Day 5; Day 12 to Day 16

  20. Part C, Cmax of EE

    Measured: Day 1; Day 12

  21. Part C, Cmax of NET

    Measured: Day 1 and Day 12

Secondary outcomes (12)

  1. Part A, Number of Participants With Treatment-emergent Adverse Events (TEAEs) for single or multiple doses of E2086, ITZ, and CBZ

    Measured: ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18

  2. Part A, Number of Participants With Abnormal Laboratory Parameter Values for single or multiple doses of E2086, ITZ, and CBZ

    Measured: ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18

  3. Part A, Number of Participants With Clinically Significant Change in Vital Sign Values for single or multiple doses of E2086, ITZ, and CBZ

    Measured: ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18

  4. Part A, Number of Participants With Clinically Significant Change in 12-Lead Electrocardiogram (ECG) Values for single or multiple doses of E2086, ITZ, and CBZ

    Measured: ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18

  5. Part B, Number of Participants With TEAEs for single or multiple doses of E2086, MDZ, DEX, or BUP

    Measured: Baseline up to Day 24

  6. Part B, Number of Participants With Abnormal Laboratory Parameter Values for single or multiple doses of E2086, MDZ, DEX, or BUP

    Measured: Baseline up to Day 24

  7. Part B, Number of Participants With Clinically Significant Change in Vital Sign Values for single or multiple doses of E2086, MDZ, DEX, or BUP

    Measured: Baseline up to Day 24

  8. Part B, Number of Participants With Clinically Significant Change in 12-Lead ECG Values for single or multiple doses of E2086, MDZ, DEX, or BUP

    Measured: Baseline up to Day 24

  9. Part C, Number of Participants With TEAEs for coadministration of E2086 and combined oral contraceptive (COC)

    Measured: Baseline up to Day 18

  10. Part C, Number of Participants With Abnormal Laboratory Parameter Values for coadministration of E2086 and COC

    Measured: Baseline up to Day 18

  11. Part C, Number of Participants With Clinically Significant Change in Vital Sign Values for coadministration of E2086 and COC

    Measured: Baseline up to Day 18

  12. Part C, Number of Participants With Clinically Significant Change in 12-Lead ECG Values for coadministration of E2086 and COC

    Measured: Baseline up to Day 18

Timeline

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

  1. First posted14 Aug 2026
  2. Study start12 Aug 2026
  3. Primary completion12 Nov 2026 (estimated)
  4. Study completion12 Nov 2026 (estimated)

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
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model description
Parts A, B, and C are a fixed-sequence crossover.
Masking
None (open label)
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07766369
Sponsor's protocol ID
E2086-A001-003
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
6 Oct 2026
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 3 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eisai Medical Information (+1-888-274-2378, esi_medinfo@eisai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A, area under concentration versus time curve from zero time (predose) to time of last quantifiable concentration AUC(0-t) of E2086 and its Metabolite M1 (time frame: Day 1 to Day 4; Day 7 to Day 13). The study lists 21 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 NCT07766369.

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 6 Oct 2026.

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