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NCT Number: NCT07766369

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Austin Clinical Research Unit (CRU)- Phase 1

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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).
  • 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)

Treatment and study plan

E2086

Drug

Specified dose on specified days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Eisai Medical Information

CONTACT

[email protected]

+1-888-274-2378

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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