A Food-Effect Study of E7386 in Healthy Participants

NCT03996226 | Completed Phase 1 FDA Drug

• 1 other identifier: E7386-A001-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Effect in Healthy Participants

Keywords

Healthy Participants; E7386; Bioavailability; Food Effect

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

E7386: Fed + Fast

EXPERIMENTAL

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.

Drug: E7386

E7386: Fast + Fed

EXPERIMENTAL

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.

Drug: E7386

Interventions

E7386 DRUG

E7386 oral tablets.

E7386: Fast + Fed; E7386: Fed + Fast

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
• Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
• Any history of major surgery, e.g., intestinal resections, hepatectomy, nephrectomy, digestive organ resection that may affect absorption, metabolism or excretion of E7386.
• Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening
• Clinically significant ECG abnormality including a marked baseline prolongation of QT/corrected QT interval (QTc) (example: repeated demonstration of a QTc interval greater than (\>) 500 milliseconds \[msec\]), or a family history of prolonged QTc syndrome or sudden death
• History of drug or alcohol misuse within 6 months prior to Screening, or who had a positive urine drug test at Screening or Baseline

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

E-7386

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 24, 2019
• Study Start: June 7, 2019
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)