Not Yet RecruitingPhase 1

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

United States93 participantsStarted 2026-08-12

Plain-language 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

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. 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.
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

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

Timeframe: Day 1; Day 7

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

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

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

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

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

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

Part B, AUC(0-t) of hydroxybupropion

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

Trial details

NCT IDNCT07766369

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-12

Contact for this trial

Eisai Medical Information

+1-888-274-2378 esi_medinfo@eisai.com

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. 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.
. 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

What they're measuring

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

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

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

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

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

Timeframe: Day 1; Day 7

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

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

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

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

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

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

Part B, AUC(0-t) of hydroxybupropion

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