ClinicalTrials.gg
RecruitingNCT07766369Updated Oct 6, 2026

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

A Phase 1 interventional study of E2086 in Healthy Volunteers, sponsored by Eisai Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

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

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 6, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
93
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Females of who did not use a highly effective method of (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 (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).
  3. Subjects who are using steroidal hormones including for contraceptives, implants and intrauterine system, or for any other indications from 4 weeks before until study discharge from the final period
  4. 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; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system
  6. 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
  7. Any clinically abnormal symptom or organ impairment found by medical history at Screening, including estimated (eGFR) \<90 milliliters per minute (ml/min), and physical examinations, vital signs, findings, or laboratory test results that require medical treatment at Screening or Baseline
  8. A prolonged /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
  9. Systolic blood pressure >140 millimeters of mercury (mmHg) or diastolic blood pressure >90 mmHg at Screening or Baseline
  10. Heart rate \<50 beats per (/) min or >100 beats/min 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).
  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, and anxiety disorders [if ever treated with medication]).
  13. Known history of clinically significant drug allergy at Screening
  14. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
  15. Known to be (HIV) positive at Screening
  16. 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.
  17. Currently enrolled in another clinical study or used any drug or device within 28 days (or 5 half-lives, whichever is longer) preceding informed consent
  18. Use of illegal recreational drugs and marijuana
  19. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing.
  20. A history of noncompliance in any previous study or inability to comply with study conduct, as assessed by the investigator
  21. Any other findings that the investigator feels would increase the risk of having an adverse outcome from participating in the study
  22. Subjects carrying human leukocyte antigen (HLA)-B*1502 or HLA-A*3101 (only Part A -CBZ treatment group)
  23. Genetically determined poor metabolizers of CYP2D6 substrates (only Part B - MDZ, DEX, and BUP)
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
93 participants (estimated)

Study arms

  • Experimental
    Part A: E2086 + Itraconazole

    Oral doses of E2086 in healthy male and female participants dosed alone or in combination with itraconazole at steady state

    Drug: E2086

  • Experimental
    Part A: E2086 + Carbamazepine

    Oral doses of E2086 in healthy male and female participants dosed alone or in combination with carbamazepine at steady state

    Drug: E2086

  • Experimental
    Part B: E2086 + Midazolam + Dextromethorphan + Bupropion

    Oral doses of midazolam, dextromethorphan, and bupropion in healthy male and female participants dosed alone or in combination with E2086 at steady state

    Drug: E2086

  • Experimental
    Part C: E2086 + Ethinyl estradiol + Norethindrone

    Single dose combined oral contraceptive (ethinyl estradiol and norethindrone) healthy female participants dosed alone or in combination with E2086 at steady state

    Drug: E2086

Interventions

  • DrugE2086

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: Day 1 to Day 4; Day 7 to Day 13

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

    Time frame: Day 1; Day 7

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

    Time frame: Day 1 to Day 4; Day 15 to Day 18

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

    Time frame: Day 1 to Day 4; Day 15 to Day 18

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

    Time frame: Day 4 to Day 8; Day 18 to Day 22

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

    Time frame: Day 4 to Day 8; Day 18 to Day 22

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

    Time frame: Day 1 to Day 4; Day 15 to Day 18

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

    Time frame: Day 1 to Day 4; Day 15 to Day 18

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

    Time frame: Day 4 to Day 8; Day 18 to Day 22

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

    Time frame: Day 4 to Day 8; Day 18 to Day 22

  12. Part B, Cmax of MDZ

    Time frame: Day 1 and Day 15

  13. Part B, Cmax of DEX

    Time frame: Day 1 and Day 15

  14. Part B, Cmax of BUP

    Time frame: Day 4 and Day 18

  15. Part B, Cmax of hydroxybupropion

    Time frame: Day 4 and Day 18

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

    Time frame: Day 1 to Day 5; Day 12 to Day 16

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

    Time frame: Day 1 to Day 5; Day 12 to Day 16

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

    Time frame: Day 1 to Day 5; Day 12 to Day 16

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

    Time frame: Day 1 to Day 5; Day 12 to Day 16

  20. Part C, Cmax of EE

    Time frame: Day 1; Day 12

  21. Part C, Cmax of NET

    Time frame: Day 1 and Day 12

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline up to Day 24

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

    Time frame: Baseline up to Day 18

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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline up to Day 18

07

Study locations

1 of 1 sites recruiting
  • PPD Austin Clinical Research Unit (CRU)- Phase 1
    Austin, Texas 78744, United States
    Recruiting
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

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 14, 2026
StartActual
Aug 12, 2026
Primary completionEst.
Nov 12, 2026
CompletionEst.
Nov 12, 2026
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 6, 2026
Sites
PPD Austin Clinical Research Unit (CRU)- Phase 1 is now Recruiting
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Not yet recruiting→Recruiting
    PPD Austin Clinical Research Unit (CRU)- Phase 1 is now Recruiting
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07766369
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Aug 12, 2026
Primary completion
Nov 12, 2026 (estimated)
Completion
Nov 12, 2026 (estimated)
Last update
Oct 6, 2026

Study contacts

Eisai Medical Information
Contact
esi_medinfo@eisai.com
+1-888-274-2378

Oversight

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

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Studies of the drug tested here: Ledasorexton

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