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

← catalyst calendar

NCT07766369 · readout in 85 d

Sponsored by Eisai Inc. (industry) · 4523.T — their whole pipeline →.

Phase
Phase 1
Status
Not yet recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
93estimated
Sites
1
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2026-08-12estimatedWhen the study began enrolling
Primary completion2026-11-12estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-11-12estimatedThe whole study's end, after follow-up
First posted2026-08-14actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-14actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Healthy Volunteers

Intervention

  • Drug: E2086

Primary outcomes

what the primary-completion date above is the date OF
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
measured 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
measured Day 1 to Day 4; Day 7 to Day 13
Part A, maximum observed concentration (Cmax) of E2086 and its Metabolite M1
measured Day 1; Day 7
Part B, AUC(0-t) of midazolam (MDZ)
measured Day 1 to Day 4; Day 15 to Day 18
Part B, AUC(0-t) of dextromethorphan (DEX)
measured Day 1 to Day 4; Day 15 to Day 18
Part B, AUC(0-t) of bupropion (BUP)
measured Day 4 to Day 8; Day 18 to Day 22
Part B, AUC(0-t) of hydroxybupropion
measured Day 4 to Day 8; Day 18 to Day 22
Part B, AUC(0-inf) of MDZ
measured Day 1 to Day 4; Day 15 to Day 18
Part B, AUC(0-inf) of DEX
measured Day 1 to Day 4; Day 15 to Day 18
Part B, AUC(0-inf) of BUP
measured Day 4 to Day 8; Day 18 to Day 22
Part B, AUC(0-inf) of hydroxybupropion
measured Day 4 to Day 8; Day 18 to Day 22
Part B, Cmax of MDZ
measured Day 1 and Day 15
Part B, Cmax of DEX
measured Day 1 and Day 15
Part B, Cmax of BUP
measured Day 4 and Day 18
Part B, Cmax of hydroxybupropion
measured Day 4 and Day 18
Part C, AUC(0-t) of ethinyl estradiol (EE)
measured Day 1 to Day 5; Day 12 to Day 16
Part C, AUC(0-t) of norethindrone (NET)
measured Day 1 to Day 5; Day 12 to Day 16
Part C, AUC(0-inf) of EE
measured Day 1 to Day 5; Day 12 to Day 16
Part C, AUC(0-inf) of NET
measured Day 1 to Day 5; Day 12 to Day 16
Part C, Cmax of EE
measured Day 1; Day 12
Part C, Cmax of NET
measured Day 1 and Day 12

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