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

Eisai Clinical Trials

Protocol # E2086-A001-003

Study Overview

Study Compound: E2086

Drug Name: ledasorexton

Registry #: NCT07766369

Trial Period: Aug 2026 -

Indication: Healthy Volunteers

Primary Endpoint: 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 ]

Population
Adult males and females (age 18-55 years)
Study Status
Ongoing
Study Phase
Phase 1
Countries
United States

Clinical Trial Documents

Clinical Study Report Synopsis

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Plain Language Protocol Synopsis (PLPS)

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Plain Language Summary of Results (PLS)

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Publication reference citation

N/A

Data Sharing

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CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR