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

Part of paid clinical trials in Austin, Texas.

Sponsor
Eisai Inc.
Study ID
NCT07766369
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • E2086 — DRUG
    Specified dose on specified days

Study Details

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

Key Dates

First listed
Aug 14, 2026
Start date
Aug 12, 2026
Status verified
Aug 2026
Primary completion
Nov 12, 2026
Completion
Nov 12, 2026

Study Design

Enrollment
93 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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
  • 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
  • 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
  • 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

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PPD Austin Clinical Research Unit (CRU)- Phase 1AustinTexas78744-

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By research site
PPD Austin Clinical Research Unit (CRU)- Phase 1· Austin, TX

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