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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: pre-dose (0 hour) up to 216 hours post-dose
Awards & highlights
Study Summary
This trial tests a new drug for safety and how well it's tolerated in healthy adults and seniors.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1: pre-dose (0 hour) up to 216 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: pre-dose (0 hour) up to 216 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings
Number of Participants With Clinically Significant Abnormal Laboratory Values
+6 moreSecondary outcome measures
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for E2086 and its Metabolites
AUC(0-72h): Area Under the Plasma Concentration-time Curve From Time Zero to 72 hours Post-dose for E2086 and its Metabolites
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite for E2086 and its Metabolites
+12 moreTrial 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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
516 Previous Clinical Trials
158,983 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no major health issues that could affect the study's results.I have a history of a genetic metabolic disorder.I have a heart condition that affects my heart's electrical activity.I do not have any major health issues that could affect my safety in the study.I am between 18 and 55 years old, do not smoke, and have not smoked for at least 4 weeks.I am a woman who cannot become pregnant due to menopause or surgery.You have a history of food allergies or are currently experiencing severe allergies to things like pollen or other seasonal allergens.You have ever had thoughts of hurting yourself or have engaged in self-harming behaviors, as assessed by a specific questionnaire.I am a male not able to father a child, or my partner and I use effective birth control.I have had surgery on my liver, kidneys, or digestive organs.I am not pregnant or breastfeeding.I don't have any new or worsening symptoms that need treatment.I have a history of liver disease.I am HIV positive.I have an active Epstein Barr virus infection.A close family member has been diagnosed with bipolar type I or a psychotic disorder.I have taken over-the-counter medications in the last 2 weeks.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.I haven't received blood products in the last 4 weeks or donated blood or plasma recently.I haven't taken any biologic drugs recently, except for flu and COVID-19 vaccines.I have a history of serious heart rhythm problems.I haven't taken St. John's Wort in the last 4 weeks.I have not taken prescription drugs in the last 4 weeks.You can't have any drinks or food with caffeine in them for three days before starting the study.I haven't had a serious illness or infection needing treatment in the last 2 months.I have a history of seizures or epilepsy.I have been diagnosed with severe sleep apnea or restless legs syndrome and use a CPAP machine.You currently have mental health symptoms as determined by a standard test used to evaluate psychiatric conditions in adults.I have a history of heart issues like heart attack or heart failure.You have a history of severe allergic reactions to medications.
Research Study Groups:
This trial has the following groups:- Group 1: Part B, Cohort 8: E2086 25 mg or Placebo
- Group 2: Part A, Cohort 7: E2086 100 mg or Placebo
- Group 3: Part A, Cohort 1: E2086 1 mg or Placebo
- Group 4: Part A, Cohort 2: E2086 2.5 mg or Placebo
- Group 5: Part A, Cohort 3: E2086 5 mg or Placebo
- Group 6: Part A, Cohort 4: E2086 10 mg or Placebo
- Group 7: Part A, Cohort 5: E2086 25 mg or Placebo
- Group 8: Part A, Cohort 6: E2086 50 mg or Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How detrimental could this treatment be to individuals?
"There is minimal clinical data supporting the safety and effectiveness of this treatment, so it earned a rating of 1."
Answered by AI
What is the current size of participation in this experiment?
"Affirmative. The data hosted on clinicaltrials.gov attests to this medical study actively searching for participants, with the initial post date being 2/20/2023 and most recent update 3/9/2023. 64 individuals are required from 1 site for successful completion of the trial."
Answered by AI
Are new participants being accepted into this experiment?
"According to the information on clinicaltrials.gov, this study is proactively recruiting patients as of now. As it stands, the trial was first initiated in February 20th 2021 and recently edited on March 9th 2021."
Answered by AI
Who else is applying?
What site did they apply to?
Worldwide Clinical Trials
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Is there overnights required?
PatientReceived no prior treatments
Why did patients apply to this trial?
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