A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants
ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEisai Inc.
About 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
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Total abstinence (if it is her preferred and usual lifestyle)
Have a vasectomized partner with confirmed azoospermia
Trial design
Treatments tested in this trial
- E2086
Treatment groups
93 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov