Health TrialsbyHealthPanel

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

ConditionHealthy Volunteers
Trial statusRecruiting
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • E2086

    Drug

    Specified dose on specified days

Treatment groups

93 Participants
are divided into 4 treatment groups
Group A: Part A: E2086 + ItraconazoleExperimental treatment 1 intervention
Group B: Part A: E2086 + CarbamazepineExperimental treatment 1 intervention
Group C: Part B: E2086 + Midazolam + Dextromethorphan + BupropionExperimental treatment 1 intervention
Group D: Part C: E2086 + Ethinyl estradiol + NorethindroneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

1

Part A, Number of Participants With Treatment-emergent Adverse Events (TEAEs) for single or multiple doses of E2086, ITZ, and CBZ

Time frame
ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18
2

Part A, Number of Participants With Abnormal Laboratory Parameter Values for single or multiple doses of E2086, ITZ, and CBZ

Time frame
ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18
3

Part A, Number of Participants With Clinically Significant Change in Vital Sign Values for single or multiple doses of E2086, ITZ, and CBZ

Time frame
ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18
4

Part A, Number of Participants With Clinically Significant Change in 12-Lead Electrocardiogram (ECG) Values for single or multiple doses of E2086, ITZ, and CBZ

Time frame
ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eisai Inc.

Lead sponsor

Source ClinicalTrials.gov
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