Food Effect in Healthy Participants
Conditions
Keywords
Healthy Participants, E7386, Bioavailability, Food Effect
Brief summary
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of E7386 following single dose administration with and without a meal.
Interventions
DRUGE7386
E7386 oral tablets.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Non-smoking, healthy participants at the time of informed consent. 2. Body Mass Index (BMI) greater than (\>) 18 and less than or equal to (\<=) 30 kilogram per square meter (kg/m\^2) at Screening.
Exclusion criteria
1. 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 litre (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 2. Females of childbearing potential who: * Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following: 1. total abstinence (if it is their preferred and usual lifestyle) 2. an intrauterine device or intrauterine hormone-releasing system 3. a contraceptive implant 4. an oral contraceptive (with additional barrier method) (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation) 5. have a vasectomized partner with confirmed azoospermia * Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing) 3. Males who have not had a successful vasectomy (confirmed azoospermia) and their female partners meet the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration for E7386 | Day 1: 0-48 hours; Day 8: 0-48 hours |
| Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for E7386 | Day 1: 0-48 hours; Day 8: 0-48 hours |
| AUC0-t: AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386 | Day 1: 0-48 hours; Day 8: 0-48 hours |
| AUC0-inf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for E7386 | Day 1: 0-48 hours; Day 8: 0-48 hours |
Countries
United States
Outcome results
None listed