A Phase 1 Food-Effect Study of E7386 in Healthy Subjects

Eisai Inc.1 site in 1 country17 target enrollmentJune 7, 2019

ConditionsFood Effect in Healthy Participants

InterventionsE7386

DrugsE7386

Overview

Phase: Phase 1
Intervention: E7386
Conditions: Food Effect in Healthy Participants
Sponsor: Eisai Inc.
Enrollment: 17
Locations: 1
Primary Endpoint: AUC0-t: AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 7, 2019

End Date

October 29, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non-smoking, healthy participants at the time of informed consent.
•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

•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
•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:
•total abstinence (if it is their preferred and usual lifestyle)
•an intrauterine device or intrauterine hormone-releasing system
•a contraceptive implant
•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)
•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)
•Males who have not had a successful vasectomy (confirmed azoospermia) and their female partners meet the exclusion criteria No: 2, above. If the female partner is pregnant, then males who do not agree to use Barrier contraception (latex or synthetic condoms) throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation

Arms & Interventions

E7386: Fed + Fast

Participants will receive a single oral dose of E7386 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of E7386 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.

Intervention: E7386

E7386: Fast + Fed

Participants will receive a single oral dose of E7386 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of E7386 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.

Intervention: E7386