A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy Participants

NCT ID: NCT03451890

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2018-09-26

Brief Summary

This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of E2730 in healthy adult participants.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cohort 1: E2730 40 mg

Participants will receive a single oral dose of E2730 40 milligrams (mg) under fasted conditions.

Group Type: EXPERIMENTAL

E2730

Intervention Type: DRUG

oral capsule

Cohort 1: Matching placebo

Participants will receive a single oral dose of matching placebo under fasted conditions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral capsule

Cohort 2: E2730 80 mg

Participants will receive a single oral dose of E2730 80 mg under fasted conditions.

Group Type: EXPERIMENTAL

E2730

Intervention Type: DRUG

oral capsule

Cohort 2: Matching placebo

Participants will receive a single oral dose of matching placebo under fasted conditions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral capsule

Cohort 3: E2730 120 mg

Participants will receive a single oral dose of E2730 120 mg under fasted conditions.

Group Type: EXPERIMENTAL

E2730

Intervention Type: DRUG

oral capsule

Cohort 3: Matching placebo

Participants will receive a single oral dose of matching placebo under fasted conditions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral capsule

Cohort 4: E2730 160 mg

Participants will receive a single oral dose of E2730 160 mg under fasted conditions.

Group Type: EXPERIMENTAL

E2730

Intervention Type: DRUG

oral capsule

Cohort 4: Matching placebo

Participants will receive a single oral dose of matching placebo under fasted conditions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral capsule

Interventions

E2730

oral capsule

Intervention Type: DRUG

Placebo

oral capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-smoking, male or female, age ≥18 years and ≤55 years old at the time of informed consent (Note: To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.)
• Body mass index (BMI) ≥18 and <32 kilograms per meters squared (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 [β-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per liter (IU/L) or equivalent units of β-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.
• Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period or for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.
• Participants with history of seizures, including those experienced in childhood
• Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of E2730, e.g., hepatectomy, nephrectomy, and digestive organ resection
• A prolonged QT/QTc interval (QTcF >450 milliseconds) demonstrated by a repeated ECG at Screening or Baseline (based on average of triplicate ECGs). A history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QT/QTc interval
• Persistent systolic blood pressure (BP) >139 or <90 millimeters of mercury (mmHg) or diastolic BP >89 or <50 mmHg at Screening or Baseline
• Left bundle branch block
• History of myocardial infarction or active ischemic heart disease
• History of clinically significant arrhythmia or uncontrolled arrhythmia
• Known history of clinically significant drug allergy at Screening
• Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
• Known to be human immunodeficiency virus (HIV) positive at Screening
• Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
• History of drug or alcohol dependency or abuse, or those who have a positive drug test at Screening or Baseline
• Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 half-lives, whichever is longer, preceding informed consent
• Participants who undergo blood transfusion within 12 weeks, or who donate 400 milliliters (mL) or more of whole blood within 12 weeks or 200 mL or more of whole blood within 4 weeks, or who make a component donation within 2 weeks prior to dosing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Collaborative Neuroscience Network

Long Beach, California, United States

Countries

United States

Other Identifiers

E2730-A001-002

Identifier Type: -

Identifier Source: org_study_id