A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants

A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E8001 in Healthy Male Subjects

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E8001 of single ascending dose intravenous infusions in healthy male participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: E8001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Minato-ku, Japan
    • Eisai Trial Site #1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Non-smoking, age greater than or equal to (>=) 20 years and less than or equal to (<=) 55 years old adult male at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing
2. Body mass index (BMI) >=18.5 and less than (<) 25.0 kilogram per square meter (kg/m˄2) at Screening

Exclusion Criteria:

1. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria (that is, 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
2. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
3. History of meningococcal infection or pneumococcal infection
4. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example- 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
5. Any history of gastrointestinal surgery that may affect PK profiles of E8001, example- hepatectomy, nephrectomy, and digestive organ resection at Screening
6. Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline
7. History of prolonged QT/QTc interval
8. History of left bundle branch block (LBBB)
9. History of myocardial infarction (MI) or active ischemic heart disease (IHD)
10. History of clinically significant arrhythmia or uncontrolled arrhythmia
11. Active viral hepatitis (A, B or C) and syphilis as demonstrated by positive serology at Screening
12. History of drug or alcohol dependency or abuse, or those who have a positive drug test at Screening or Baseline

13. Liver function test with following values at Screening or Baseline:

    1. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or gamma glutamyl transpeptidase (GGT): greater than (>) upper limit of normal (ULN)
    2. direct bilirubin or total bilirubin: >1.5*ULN

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: E8001 or Placebo; Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.	Drug: E8001; Intravenous infusion.; Drug: Placebo; Intravenous infusion.
Experimental: Cohort 2: E8001 or Placebo; Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.	Drug: E8001; Intravenous infusion.; Drug: Placebo; Intravenous infusion.
Experimental: Cohort 3: E8001 or Placebo; Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.	Drug: E8001; Intravenous infusion.; Drug: Placebo; Intravenous infusion.
Experimental: Cohort 4: E8001 or Placebo; Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.	Drug: E8001; Intravenous infusion.; Drug: Placebo; Intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs; regular monitoring of clinical laboratory parameters; and periodic measurement of vital signs and 12-lead electrocardiogram (ECG), body weight and physical examinations.	Screening up to Day 180 (approximately 292 days)
Cmax: Maximum Observed Plasma Concentration for E8001		Day 1: 0-168 hours
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001		Day 1: 0-168 hours
AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E8001		Day 1: 0-168 hours
T1/2: Terminal Elimination Phase Half-life for E8001		Day 1: 0-168 hours
CL: Total Clearance for E8001		Day 1: 0-168 hours
Vss: Volume of Distribution at Steady State for E8001		Day 1: 0-168 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Corrected QT (QTc) Interval	To assess the effect of E8001 on ventricular repolarization by assessing the QTc interval corrected by the Fridericia formula (QTcF).	Day 1: 0-24 hours

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Healthy Participants; E8001
• Other Study ID Numbers: E8001-J081-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No