E2086 Drug Interaction Study in Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
This trial is for healthy adults who do not have any significant medical conditions. Participants should not be taking medications that could interfere with the study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive oral doses of E2086 alone or in combination with itraconazole or carbamazepine at steady state
Treatment Part B
Participants receive oral doses of midazolam, dextromethorphan, and bupropion alone or in combination with E2086 at steady state
Treatment Part C
Female participants receive a single dose of combined oral contraceptive (ethinyl estradiol and norethindrone) alone or in combination with E2086 at steady state
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- E2086
Trial Overview
The study tests how E2086 interacts with other common drugs (Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, and oral contraceptives) when taken together by mouth in healthy people.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Single dose combined oral contraceptive (ethinyl estradiol and norethindrone) healthy female participants dosed alone or in combination with E2086 at steady state
Oral doses of midazolam, dextromethorphan, and bupropion in healthy male and female participants dosed alone or in combination with E2086 at steady state
Oral doses of E2086 in healthy male and female participants dosed alone or in combination with itraconazole at steady state
Oral doses of E2086 in healthy male and female participants dosed alone or in combination with carbamazepine at steady state
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eisai Inc.
Lead Sponsor
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University
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