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

NCT07766369 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: E2086-A001-003
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (21)

• 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

  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

  Day 1 to Day 4; Day 7 to Day 13

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

  Day 1; Day 7

• Part B, AUC(0-t) of midazolam (MDZ)

  Day 1 to Day 4; Day 15 to Day 18

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

  Day 1 to Day 4; Day 15 to Day 18

• Part B, AUC(0-t) of bupropion (BUP)

  Day 4 to Day 8; Day 18 to Day 22

• Part B, AUC(0-t) of hydroxybupropion

  Day 4 to Day 8; Day 18 to Day 22

• Part B, AUC(0-inf) of MDZ

  Day 1 to Day 4; Day 15 to Day 18

• Part B, AUC(0-inf) of DEX

  Day 1 to Day 4; Day 15 to Day 18

• Part B, AUC(0-inf) of BUP

  Day 4 to Day 8; Day 18 to Day 22

• Part B, AUC(0-inf) of hydroxybupropion

  Day 4 to Day 8; Day 18 to Day 22

• Part B, Cmax of MDZ

  Day 1 and Day 15

• Part B, Cmax of DEX

  Day 1 and Day 15

• Part B, Cmax of BUP

  Day 4 and Day 18

• Part B, Cmax of hydroxybupropion

  Day 4 and Day 18

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

  Day 1 to Day 5; Day 12 to Day 16

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

  Day 1 to Day 5; Day 12 to Day 16

• Part C, AUC(0-inf) of EE

  Day 1 to Day 5; Day 12 to Day 16

• Part C, AUC(0-inf) of NET

  Day 1 to Day 5; Day 12 to Day 16

• Part C, Cmax of EE

  Day 1; Day 12

• Part C, Cmax of NET

  Day 1 and Day 12

Secondary Outcomes (12)

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

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

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

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

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

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

• 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

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

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

  Baseline up to Day 24

Study Arms (4)

Part A: E2086 + Itraconazole

EXPERIMENTAL

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

Drug: E2086

Part A: E2086 + Carbamazepine

EXPERIMENTAL

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

Drug: E2086

Part B: E2086 + Midazolam + Dextromethorphan + Bupropion

EXPERIMENTAL

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

Part C: E2086 + Ethinyl estradiol + Norethindrone

EXPERIMENTAL

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

E2086 DRUG

Specified dose on specified days

Part A: E2086 + Carbamazepine; Part A: E2086 + Itraconazole; Part B: E2086 + Midazolam + Dextromethorphan + Bupropion; Part C: E2086 + Ethinyl estradiol + Norethindrone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

PPD Austin Clinical Research Unit (CRU)- Phase 1

Austin, Texas, 78744, United States

Location

Central Study Contacts

Eisai Medical Information

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parts A, B, and C are a fixed-sequence crossover.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: August 12, 2026
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): November 12, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)