What side effects are associated with this type of intervention?

In studies assessing the safety and tolerability of treatments in healthy subjects, common side effects often include mild to moderate adverse events such as fatigue, dizziness, somnolence, and gastrointestinal issues like nausea and vomiting. For example, in the study of ODM-201, the most common treatment-emergent adverse events were fatigue or asthenia, hot flushes, and decreased appetite. Similarly, other treatments have reported somnolence, dizziness, and psychological issues such as irritability. These side effects are generally mild and manageable.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects often focus on early-phase clinical trials assessing the safety and tolerability of new drugs. These studies, like the one for E2086, are crucial for determining the initial safety profile of a drug before it is tested in patients with specific conditions. While specific drugs similar to E2086 are not mentioned, this type of study is a standard part of the drug development process to ensure that new treatments are safe for further testing.

What other types of research exist?

A promising novel alternative to E2086 for safety and tolerability assessment in healthy subjects could be GC2008, an anti-TGF-β antibody, which has shown informed dose projection and pharmacologically relevant doses in early clinical settings. Additionally, the flexible, rule-based dose escalation method described in the cohort-sequence design could be considered for its ability to rapidly identify maximum tolerated doses (MTD) without unnecessary patient enrollment at low doses.

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E2086 for Healthy Subjects

Q: What is the mechanism of action of this treatment?

The mechanisms of action for common treatments in healthy subjects, such as those being studied in the E2086 trial, typically involve evaluating how the drug is processed by the body (pharmacokinetics) and its effects on the body (pharmacodynamics). This is crucial for establishing the safety and tolerability of the drug, determining potential side effects, and identifying the optimal dosing regimen. Understanding these mechanisms in healthy subjects helps ensure that future clinical trials in patients with specific conditions can be conducted safely and effectively.

Phase 1

Waitlist Available

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 international units per liter (IU/L) or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the dose of study drug.

Any history of a congenital abnormality in metabolism at Screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening up to 10 days

Summary

This trial tests a new drug called E2086 to see if it is safe for healthy adults and elderly people.

Who is the study for?

Adults aged 18-55 (and 65+ for part B), non-smokers, with regular sleep patterns, a BMI of 18 to <30 kg/m^2. Excluded are those with significant allergies, suicidal history, uncontrolled diseases, drug/alcohol abuse in the past two years, recent investigational drug use or blood donation, and women who are pregnant or not using effective contraception.

What is being tested?

The trial is testing E2086's safety and tolerability by giving healthy adults single oral doses compared to a placebo. The study will monitor how the body reacts to this medication over time.

What are the potential side effects?

While specific side effects aren't listed for E2086 as it's under investigation, common ones may include nausea, headache, dizziness or fatigue. Participants will be monitored closely for any adverse reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have a history of a genetic metabolic disorder.

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I have a history of seizures or epilepsy.

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I have had surgery on my liver, kidneys, or digestive organs.

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I don't have any new or worsening symptoms that need treatment.

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I have a history of liver disease.

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I have a history of heart issues like heart attack or heart failure.

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I have a history of serious heart rhythm problems.

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I am HIV positive.

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I have an active Epstein Barr virus infection.

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I have not participated in another clinical study or used any investigational drug or device within the last 30 days or 5 half-lives, whichever is longer.

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I have been diagnosed with severe sleep apnea or restless legs syndrome and use a CPAP machine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening up to 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening up to 10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)

Secondary study objectives

Mean Change in Subjective Sleep Onset Latency (sSOL)

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part B, Cohort 8: E2086 25 mg or PlaceboExperimental Treatment2 Interventions

Participants will receive 25 mg (1\*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1.

Group II: Part A, Cohort 7: E2086 100 mg or PlaceboExperimental Treatment2 Interventions

Participants will receive 100 mg (4\*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1.

Group III: Part A, Cohort 6: E2086 50 mg or PlaceboExperimental Treatment2 Interventions

Participants will receive 50 mg (2\*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1.

Group IV: Part A, Cohort 5: E2086 25 mg or PlaceboExperimental Treatment2 Interventions

Participants will receive 25 mg (1\*25 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1.

Group V: Part A, Cohort 4: E2086 10 mg or PlaceboExperimental Treatment2 Interventions

Participants will receive 10 mg (2\*5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1.

Group VI: Part A, Cohort 3: E2086 5 mg or PlaceboExperimental Treatment2 Interventions

Participants will receive 5 mg (1\*5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1.

Group VII: Part A, Cohort 2: E2086 2.5 mg or PlaceboExperimental Treatment2 Interventions

Participants will receive 2.5 mg (5\*0.5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1.

Group VIII: Part A, Cohort 1: E2086 1 mg or PlaceboExperimental Treatment2 Interventions

Participants will receive 1 milligram (mg) (2\*0.5 mg) E2086 or E2086 matched placebo, tablets, orally, once on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

E2086

2023

Completed Phase 1

~60

Placebo

1995

Completed Phase 3

~2670

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The mechanisms of action for common treatments in healthy subjects, such as those being studied in the E2086 trial, typically involve evaluating how the drug is processed by the body (pharmacokinetics) and its effects on the body (pharmacodynamics). This is crucial for establishing the safety and tolerability of the drug, determining potential side effects, and identifying the optimal dosing regimen. Understanding these mechanisms in healthy subjects helps ensure that future clinical trials in patients with specific conditions can be conducted safely and effectively.

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