A Study of E2086 in Healthy Adult Participants

Phase 1

Recruiting

• Conditions: Healthy Volunteers

• Registration Number: NCT06481488
• Lead Sponsor: Eisai Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-6-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Non-smoking, male or female, aged greater than or equal to (>=) 18 years to less<br> than or equal to (<=) 55 years (>=20 years to <=55 years for Japanese participants)<br> at the time of informed consent. To be considered non-smokers, participants must<br> have discontinued smoking for at least 4 weeks before dosing<br><br> 2. Japanese participants must have been born in Japan of Japanese parents and Japanese<br> grandparents, must have lived no more than 5 years outside of Japan, and must not<br> have changed their lifestyle or habits, including diet, while living outside of<br> Japan<br><br> 3. Body mass index (BMI) >=18 to less than (<) 30 kilogram per square meter (kg/m^2) at<br> screening only for Part A<br><br> 4. Reports regular bedtime, defined as the time the participant attempts to sleep,<br> between 22:00 and midnight<br><br> 5. Reports regular waketime, defined as the time the participant gets out of bed for<br> the day, between 05:00 and 10:00<br><br>Exclusion Criteria:<br><br> 1. Females who are breastfeeding or pregnant at screening or baseline (as documented by<br> a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic<br> gonadotropin [hCG]) test with a minimum sensitivity of 25 international units per<br> liter (IU/L) or equivalent units of ß-hCG [or hCG]). A separate baseline assessment<br> is required if a negative screening pregnancy test was obtained more than 72 hours<br> before the dose of study drug<br><br> 2. All females who are of childbearing potential: All females will be considered to be<br> of childbearing potential unless they are postmenopausal (amenorrheic for at least<br> 12 consecutive months, in the appropriate age group, and without other known or<br> suspected cause) or have been sterilized surgically (that is, bilateral tubal<br> ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1<br> month before dosing)<br><br> 3. Males who have not had a successful vasectomy (confirmed azoospermia) or their<br> female partners do not meet the criteria above (that is, not of childbearing<br> potential) or practicing highly effective contraception throughout the study period<br> or for 28 days after study drug discontinuation. No sperm donation is allowed during<br> the study period and for 92 days after study drug discontinuation<br><br> 4. Clinically significant illness that requires medical treatment within 8 weeks or a<br> clinically significant infection that requires medical treatment within 4 weeks of<br> dosing<br><br> 5. Evidence of disease that may influence the outcome of the study within 4 weeks<br> before dosing; example, psychiatric disorders and disorders of the gastrointestinal<br> tract, liver, kidney, respiratory system, endocrine system, hematological system,<br> neurological system, or cardiovascular system<br><br> 6. Any history of surgery that may affect pharmacokinetic (PK) profiles of E2086,<br> example, hepatectomy, nephrotomy, digestive organ resection or participants who have<br> a congenital abnormality in metabolism<br><br> 7. Any clinically abnormal symptom or organ impairment found by medical history at<br> screening, and physical examinations, vital signs, ECG finding, or laboratory test<br> results that require medical treatment at screening or baseline<br><br> 8. Evidence of clinically significant disease (example, cardiac, respiratory,<br> gastrointestinal, renal disease, sleep disorders) that in the opinion of the<br> investigators could affect the participant's safety or interfere with the study<br> assessments<br><br> 9. A prolonged QT/QTc interval (QTcF greater than [>] 450 milliseconds [ms])<br> demonstrated on ECG at screening or baseline (based on average of triplicate ECGs).<br> A history of risk factors for torsade de pointes (example, heart failure,<br> hypokalemia, family history of long QT Syndrome) or the use of concomitant<br> medications that prolonged the QT/QTc interval<br><br> 10. Left bundle branch block at screening or baseline<br><br> 11. Persistent systolic blood pressure (BP) >130 or <100 millimeters of mercury (mmHg)<br> or diastolic BP >85 or <50 mmHg at screening or baseline (based on BP measured on at<br> least 3 occasions over 2 weeks)<br><br> 12. Persistent heart rate (HR) <50 bpm or >100 bpm at screening or baseline (based on HR<br> measured on at least 3 occasions over 2 weeks)<br><br> 13. History of myocardial infarction, ischemic heart disease, or cardiac failure<br><br> 14. History of clinically significant arrhythmia or uncontrolled arrhythmia<br><br> 15. Any lifetime history of suicidal ideation or any lifetime history of suicidal<br> behavior as indicated by the C-SSRS<br><br> 16. Any lifetime history of psychiatric disease (including but not limited to depression<br> or other mood disorders, bipolar disorder, psychotic disorders, including<br> schizophrenia, panic attacks, anxiety disorders)<br><br> 17. Any current psychiatric symptoms as indicated by a standard screening tool<br> (Diagnostic and Statistical Manual of Mental Disorders Self-Rated Level 1<br> Cross-Cutting Symptom Measure - Adult)<br><br> 18. Participants with 1 or more first degree (blood) relatives who have lifetime<br> diagnosis of bipolar type I disorder or a psychotic disorder<br><br> 19. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or<br> donation of plasma within 1 week of dosing<br><br> 20. History of formally diagnosed moderate to severe obstructive sleep apnea, current<br> use of continuous positive airway pressure, or symptomatic restless legs syndrome

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs);Part A: Number of Participants With Serious Adverse Events (SAEs);Part A: Number of Participants With Clinically Significant Abnormal Laboratory Parameters;Part A: Number of Participants With Clinically Significant Abnormal Vital Signs Values;Part A: Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings;Part A: Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings;Part A: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS);Part B: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS