E2086 for Healthy Subjects

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Eisai Inc.

Must not be taking: Statins, Illegal drugs

Disqualifiers: Radiation exposure, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the new drug E2086 is processed and eliminated by the body in healthy males. Researchers seek to determine how the body breaks down this drug and how it exits the system. The trial seeks healthy, non-smoking men who haven't recently participated in many radiolabeled drug studies. Participants should also be free from significant medical conditions or recent illnesses. As a Phase 1 trial, this study focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have started or changed statin therapy in the last 6 months, you may not be eligible. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that E2086 has been tested for safety in healthy adults. Studies found that both single and multiple doses of E2086 are generally well-tolerated. Most participants did not experience serious side effects. Common mild side effects included headaches and tiredness, which were usually short-lived and manageable. These findings provide confidence in the safety of E2086 for further studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

E2086 is unique because it represents a new frontier in treatment development. While most treatments for conditions like epilepsy or chronic pain rely on traditional mechanisms, E2086 is designed to interact with specific neurological pathways in a novel way, potentially leading to more effective symptom management. Researchers are excited because this could mean fewer side effects and a more targeted approach compared to existing medications, which often involve broad action throughout the brain. This specificity might offer improved outcomes for patients who have not found relief with current options.

What evidence suggests that E2086 could be effective?

Research has shown that E2086 might help people with narcolepsy type 1 feel more awake during the day. Narcolepsy causes excessive sleepiness when alertness is needed. Studies have found that taking E2086 once daily can boost the activity of orexin receptors, which help control sleep and wakefulness. This suggests E2086 could help people with narcolepsy stay awake during the day. However, more research is needed to fully understand its effects and potential benefits. Participants in this trial will receive E2086 to further evaluate its effects in healthy subjects. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for non-smoking, healthy men aged 18 to 55 with a BMI of 18-30 kg/m2. Participants must provide written consent and be able to follow the study protocol.

Inclusion Criteria

I have signed the consent form.

I am willing and able to follow all study requirements.

I am a healthy male, aged 18-55, and I do not smoke or vape.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of radiolabeled [14C]E2086

1 day

1 visit (in-person)

Follow-up

Participants are monitored for metabolism and excretion of [14C]E2086

Up to 21 days

Multiple visits (in-person)

Extended Follow-up

Further characterization of metabolites in plasma, urine, and feces

Up to 70 days

What Are the Treatments Tested in This Trial?

Interventions

• E2086

Trial Overview

The study aims to understand how the drug E2086 is metabolized and excreted in healthy male participants after they have taken it.

How Is the Trial Designed?

Group I: E2086 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Citations

1.

eisai.com

eisai.com/news/2025/news202562.html

Eisai Presents Clinical Study Results of Novel Orexin ...

These data demonstrate that once-daily dosing of E2086 has the potential to improve daytime wakefulness in individuals with narcolepsy type 1 ( ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06462404

NCT06462404 | A Study to Evaluate the Efficacy, Safety, ...

The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime ...

3.

prnewswire.com

prnewswire.com/news-releases/eisai-presents-clinical-study-results-of-novel-orexin-receptor-agonist-e2086-for-narcolepsy-at-world-sleep-2025-302548578.html

Eisai Presents Clinical Study Results of Novel Orexin ...

These data demonstrate that once-daily dosing of E2086 has the potential to improve daytime wakefulness in individuals with narcolepsy type 1 ( ...

4.

biospace.com

biospace.com/press-releases/eisai-to-present-latest-data-on-lemborexant-and-novel-orexin-receptor-agonist-e2086-at-the-world-sleep-2025

Eisai to Present Latest Data on Lemborexant and Novel ...

E2086 has the potential to improve patients' symptoms by enhancing orexin receptor activity. About narcolepsy. Narcolepsy is a chronic sleep ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05745207

NCT05745207 | A Study To Assess the Safety, Tolerability, ...

The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05745207

NCT05745207 | A Study To Assess the Safety, Tolerability ...

The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06481488

A Study of E2086 in Healthy Adult Participants

The primary purpose of the study is to evaluate the safety and tolerability following multiple ascending doses of E2086 in healthy adult participants. ... E2086 ...

8.

clinicaltrial.be

clinicaltrial.be/en/details/447264?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Study to Evaluate the Efficacy, Safety, and Tolerabilit...

The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of ...

9.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-assess-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-e2086-in-healt

A Study To Assess the Safety, Tolerability, Pharmacokinetics ...

The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and ...