Metabolism and excretion of radiolabeled E2086 in healthy men

An Open-Label, Single Dose Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants

This will test how a single dose of radiolabeled E2086 is processed and eliminated by healthy men aged 18–55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Male
• Sponsor: Eisai Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Madison, Wisconsin)
• Trial ID: NCT07308236 on ClinicalTrials.gov

What this trial studies

This Phase 1 trial gives a single dose of [14C]E2086 to healthy, non-smoking men to measure how the drug is absorbed, metabolized, and excreted. Blood, urine, and feces will be collected over several days to track the radiolabeled compound and its metabolites and to calculate total recovery. Participants must be 18–55 years old with BMI 18–<30 and able to stay at the Fortrea Clinical Research Unit in Madison, Wisconsin for inpatient monitoring and follow-up visits. The sponsor is Eisai Inc., and the data will inform dosing and safety decisions for later clinical development.

Who should consider this trial

Good fit: Ideal candidates are healthy, non-smoking men aged 18–55 with BMI between 18 and less than 30 who can provide informed consent and comply with inpatient monitoring.

Not a fit: Women, current smokers or vapers, people outside the age or BMI ranges, and anyone seeking therapeutic benefit are unlikely to gain direct medical benefit from participation.

Why it matters

Potential benefit: If successful, the results could help researchers set safer doses and monitor drug exposure in future patient studies of E2086.

How similar studies have performed: Radiolabeled ADME (absorption, distribution, metabolism, excretion) studies like this are well-established and have reliably guided dosing and safety for many drugs.

Eligibility criteria

Inclusion Criteria:

1. 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
2. Body Mass Index (BMI) \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening
3. Provide written informed consent
4. Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

1. 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.
2. 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.
3. 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.

   NOTE: All female partners of male participants will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). Examples of highly effective contraception include total abstinence, an intrauterine device, a double-barrier method (such as condom plus diaphragm with spermicide), a contraceptive implant, and oral contraceptive. Female partners of male participants who have not had a successful vasectomy, who use hormonal contraception, must be on the same hormonal contraceptive for 28 days before the male participants are dosed with trial drug, throughout the trial period and for 28 days afterwards.
4. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
5. Evidence of disease that may influence the outcome of the trial within 4 weeks before dosing, eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, orbcardiovascular system.
6. Any history of surgery that may affect PK profiles of E2086 (eg, hepatectomy, nephrectomy, digestive organ resection) or participants who have a congenital abnormality in metabolism at Screening.
7. Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) findings, or laboratory test results that require medical treatment at Screening or Baseline.
8. Initiation of statin therapy, or a change to a different statin, or an increase in the dose of a statin within the 6 months before the planned start of the study
9. A prolonged QT/QTc interval (QTcF greater than (\>) 450 millisecond \[ms\]) as demonstrated by the mean of triplicate ECGs (recorded at least 1 min apart) at Screening or Baseline
10. Systolic blood pressure \>130 millimeter of mercury (mmHg) or diastolic blood pressure \>85 mmHg at Screening or Baseline
11. Heart rate \<50 beats/min or \>100 beats/min at Screening or Baseline
12. Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS).
13. Any lifetime history of psychiatric disease (including, but not limited to, depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, and anxiety disorders \[if ever treated with medication\]).
14. Known history of clinically significant drug allergy at Screening or Baseline
15. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline.
16. Known to be human immunodeficiency virus (HIV) positive at Screening
17. History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or alcohol test at Screening or Baseline.
18. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) preceding informed consent
19. Use of illegal recreational drugs and marijuana
20. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing.

Where this trial is running

Madison, Wisconsin

• Fortrea Clinical Research Unit Inc. — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Eisai Medical Information

Conditions Healthy Volunteers