Actively Recruiting

Phase 1
Age: 18Years - 55Years
MALE
Healthy Volunteers
NCT07308236

A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants

Led by Eisai Inc. · Updated on 2026-03-05

10

Participants Needed

1

Research Sites

7 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The primary purpose of this study is to determine the metabolism and excretion of \[14C\]E2086 in healthy male participants.

CONDITIONS

Official Title

A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants

Who Can Participate

Age: 18Years - 55Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male aged 18 to 55 years at time of consent
  • Non-smoking and non-vaping
  • Body Mass Index (BMI) between 18 and less than 30 kg/m² at screening
  • Able and willing to provide written informed consent
  • Willing and able to follow all study procedures
Not Eligible

You will not qualify if you...

  • Previously dosed in more than 2 radiolabeled drug studies in past 12 months with specific timing restrictions
  • Exposure to significant diagnostic or therapeutic radiation or radiation-monitored employment within 12 months prior to check-in
  • Males without successful vasectomy who or whose female partners are not using highly effective contraception during the trial and 28 days after
  • Clinically significant illness requiring treatment within 8 weeks or infection within 4 weeks of dosing
  • Evidence of disease affecting trial outcome within 4 weeks before dosing
  • History of surgery affecting drug metabolism or congenital metabolism abnormalities
  • Abnormal symptoms or organ impairment needing treatment at screening or baseline
  • Recent changes or start of statin therapy within 6 months before study
  • Prolonged QT/QTc interval greater than 450 ms at screening or baseline
  • Blood pressure over 130/85 mmHg or heart rate below 50 or over 100 beats/min at screening or baseline
  • Lifetime history of suicidal ideation or behavior
  • Lifetime history of psychiatric disease treated with medication
  • Known significant drug allergy or significant allergies at screening or baseline
  • Known HIV positive status
  • Drug or alcohol dependency or abuse within 2 years before screening or positive drug/alcohol tests at screening
  • Current enrollment in another clinical trial or recent investigational drug/device use within 30 days or 5 half-lives
  • Use of illegal recreational drugs or marijuana
  • Recent blood products receipt or blood/plasma donation within specified timeframes before dosing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, United States, 53704

Actively Recruiting

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Research Team

E

Eisai Medical Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants | DecenTrialz