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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorEisai Inc.

About this trial

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

Eligibility criteria

Qualifiers

Non-smoking and non-vaping, healthy male, age greater than or equal to (>=) 18 years and less than or equal to (<=) 55 years old at the time of informed consent

Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m²) at Screening

Provide written informed consent

Willing and able to comply with all aspects of the protocol

Disqualifiers

Have previously been dosed in more than 2 radiolabeled drug studies in the past 12 months. For participants who have previously been dosed in 2 or more radiolabeled drug studies within the last 12 months, the previous radiolabeled dose must be at least 4 months prior to check-in to the trial site where exposures are known to the investigator, or 6 months prior to check-in to the trial site for a radiolabeled drug trial where exposures are not known to the investigator. The total 12-month exposure from this trial and a maximum of 2 other previous radiolabeled studies must be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1.

Exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.

Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the following criteria: not of childbearing potential or practicing highly effective contraception throughout the trial period and for 28 days after trial drug discontinuation. No sperm donation is allowed during the trial period and for 90 days after trial drug discontinuation.

Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.

Trial design

Treatments tested in this trial

  • E2086

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators