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CompletedNCT04609852Updated Sep 25, 2023

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

A Phase 1 interventional study of E8001 and Placebo in Healthy Volunteers, sponsored by Eisai Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-25.

Sponsored by Eisai Co., Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Healthy Participants
  • E8001
03

In context

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • 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 · Drug: Placebo

  • 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 · Drug: Placebo

  • 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 · Drug: Placebo

  • 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 · Drug: Placebo

Interventions

  • DrugE8001

    Intravenous infusion.

  • DrugPlacebo

    Intravenous infusion.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Screening up to Day 180 (approximately 292 days)

  2. Cmax: Maximum Observed Plasma Concentration for E8001

    Time frame: Day 1: 0-168 hours

  3. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001

    Time frame: Day 1: 0-168 hours

  4. AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E8001

    Time frame: Day 1: 0-168 hours

  5. T1/2: Terminal Elimination Phase Half-life for E8001

    Time frame: Day 1: 0-168 hours

  6. CL: Total Clearance for E8001

    Time frame: Day 1: 0-168 hours

  7. Vss: Volume of Distribution at Steady State for E8001

    Time frame: Day 1: 0-168 hours

Secondary outcomes

  1. 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).

    Time frame: Day 1: 0-24 hours

07

Study locations

1 site
  • Eisai Trial Site #1
    Minato-ku, Japan
08

References and documents

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04609852
Lead sponsor
Eisai Co., Ltd.
Responsible party
Sponsor
First posted
Oct 30, 2020
Start date
Oct 28, 2020
Primary completion
Aug 18, 2023
Completion
Aug 18, 2023
Last update
Sep 25, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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