E2086: See if it interacts with other drugs when taken with common medications
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
Run by Eisai Inc. · NCT07766369 · Data updated 2026-11-12
This small early study tests whether E2086 changes the way certain medicines work when taken together in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 93 (estimated) |
| Sponsor | Eisai Inc. Industry-sponsored |
| Locations | 1 site (Austin, Texas) |
| Status | Recruiting |
| Started | August 12, 2026 |
| Main results expected | November 12, 2026 |
| Study ends | November 12, 2026 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07766369 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–55 who are non-smokers/non-vapers, with BMI 18–30 kg/m2, and who are eligible for all parts of the protocol.
✕Probably not a fit
Participants may not directly benefit from the study and are exposed to procedures without therapeutic effect.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1 interventional trial looks at potential drug-drug interactions between a single oral dose of E2086 and several commonly used medications (itraconazole, carbamazepine, midazolam, dextromethorphan, bupropion, and combined oral contraceptives) in healthy volunteers. Participants are healthy adults aged 18 to 55, non-smokers or non-vapers, with BMI 18–30 kg/m2, and are evaluated in a single-center Phase 1 setting in Austin, Texas. The study aims to identify changes in safety, pharmacokinetics, and overall tolerability when E2086 is coadministered with these drugs. Details on specific endpoints and dosing are not provided in the overview. The sponsor is Eisai Inc., with the research conducted at PPD Austin CRU.
Why it matters
Potential benefit: If successful, the study could clarify whether E2086 can be safely co-administered with common medications.
How similar studies have gone: Pharmacokinetic interaction studies with E2086 and other drugs have not been widely published; this study addresses a gap in understanding potential interactions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Body Mass Index (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 informed consent (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: 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 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). 3. 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 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; 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 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 8. 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 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 human immunodeficiency virus (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 investigational 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)
Where it's running
-
PPD Austin Clinical Research Unit (CRU)- Phase 1
Austin, Texas, United States Recruiting
Study contacts
- Study coordinator: Eisai Medical Information
- Email: esi_medinfo@eisai.com
- Phone: +1-888-274-2378
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.