A Study of E2086 in Healthy Adult Participants
NCT Number: NCT06481488
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: E2086|DRUG: Placebo
Sponsor: Eisai Inc.
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-25
Completion Date: 2024-10-16
Locations: Parexel International, Glendale, California, 91206, United States

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

Primary Outcome Measures: Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Day 10|Part A: Number of Participants With Serious Adverse Events (SAEs), Day 10|Part A: Number of Participants With Clinically Significant Abnormal Laboratory Parameters, Day 10|Part A: Number of Participants With Clinically Significant Abnormal Vital Signs Values, Day 10|Part A: Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings, Day 10|Part A: Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings, Day 8|Part A: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS), The C-SSRS is an interview-based rating scale to systematically assess any suicidality, suicidal behavior, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior is indicated when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation is indicated when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide., Day 10|Part B: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS, The C-SSRS is an interview-based rating scale to systematically assess any suicidality, suicidal behavior, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior is indicated when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation is indicated when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide., Day 7
Secondary Outcome Measures: Part A, Cmax: Maximum Observed Plasma Concentration of E2086 and its Metabolite M1, Day 1 and at steady-state|Part A, Tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) of E2086 and its Metabolite M1, Day 1 and at steady-state|Part A, Css: Average Steady State Concentration of E2086 and its Metabolite M1, Day 1 and at steady-state|Part A, AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-dose of E2086 and its Metabolite M1, Day 1|Part A, t1/2: Terminal Elimination Phase Half-life of E2086 and its Metabolite M1, Day 1 and at steady-state|Part A, Rac (Cmax): Accumulation Ratio for Cmax of E2086 and its Metabolite M1, Day 1 and at steady-state|Part A, Rac (AUC0-24h): Accumulation Ratio for AUC0-24 Hours of E2086 and its Metabolite M1, Day 1|Part A, Ae: Cumulative Amount of E2086 and its Metabolite M1 Excreted in Urine, At steady-state|Part A, CLR: Renal Clearance of E2086 and its Metabolite M1, At steady-state|Part A, Fe: Fraction of E2086 and its Metabolite M1 Excreted in Urine, At steady-state|Part A, MRU: Ratio of Cumulative Amount of Metabolite M1 to E2086 Excreted in Urine Concentration, At steady-state|Part A: Geometric Mean Ratio of Cmax Between Healthy Non-Japanese and Japanese Participants After Administration of E2086, Day 1 and at steady-state|Part A: Geometric Mean Ratio of AUC0-24 Hour Between Healthy Non-Japanese and Japanese Participants After Administration of E2086, Day 1|Part B: Geometric Mean Ratio of Cmax Between the Fasted and Fed State for Single Dose of E2086 Dose 2, After single doses in Fasted and Fed State|Part B: Geometric Mean Ratio of Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Between the Fasted and Fed State for Single Dose of E2086 Dose 2, After single doses in Fasted and Fed State|Part B: Geometric Mean Ratio of Area Under the Plasma Concentration-time Curve From Time Zero to Infinite (AUC0-inf) Between the Fasted and Fed State for Single Dose of E2086 Dose 2, After single doses in Fasted and Fed State|Part A: Change From Baseline in QTc Using the Fridericia Formula (QTcF) From Holter ECG, A central ECG laboratory will extract ECG recordings from the Holter device., Baseline to Day 8|Part A: Placebo Corrected Change From Baseline in QTcF Using Holter ECG, A central ECG laboratory will extract ECG recordings from the Holter device., Baseline to Day 8|Part A: Change From Baseline in Subjective Sleep Onset Latency (sSOL), sSOL is a participant-reported parameter. Sleep onset latency is a measure of how long it takes for the participant to fall asleep once the participant gets into bed. This will be measured in minutes., Baseline to Day 10