The primary purpose of the study is to evaluate the safety and tolerability following multiple ascending doses of E2086 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
32
Parexel International
Glendale, California, United States
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 10
Part A: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Day 10
Part A: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Time frame: Day 10
Part A: Number of Participants With Clinically Significant Abnormal Vital Signs Values
Time frame: Day 10
Part A: Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Time frame: Day 10
Part A: Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings
Time frame: 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.
Time frame: Day 10
Part B: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
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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.
Time frame: Day 7
Part A, Cmax: Maximum Observed Plasma Concentration of E2086 and its Metabolite M1
Time frame: Day 1 and at steady-state
Part A, Tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) of E2086 and its Metabolite M1
Time frame: Day 1 and at steady-state
Part A, Css: Average Steady State Concentration of E2086 and its Metabolite M1
Time frame: 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
Time frame: Day 1
Part A, t1/2: Terminal Elimination Phase Half-life of E2086 and its Metabolite M1
Time frame: Day 1 and at steady-state
Part A, Rac (Cmax): Accumulation Ratio for Cmax of E2086 and its Metabolite M1
Time frame: Day 1 and at steady-state
Part A, Rac (AUC0-24h): Accumulation Ratio for AUC0-24 Hours of E2086 and its Metabolite M1
Time frame: Day 1
Part A, Ae: Cumulative Amount of E2086 and its Metabolite M1 Excreted in Urine
Time frame: At steady-state
Part A, CLR: Renal Clearance of E2086 and its Metabolite M1
Time frame: At steady-state
Part A, Fe: Fraction of E2086 and its Metabolite M1 Excreted in Urine
Time frame: At steady-state
Part A, MRU: Ratio of Cumulative Amount of Metabolite M1 to E2086 Excreted in Urine Concentration
Time frame: At steady-state
Part A: Geometric Mean Ratio of Cmax Between Healthy Non-Japanese and Japanese Participants After Administration of E2086
Time frame: 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
Time frame: Day 1
Part B: Geometric Mean Ratio of Cmax Between the Fasted and Fed State for Single Dose of E2086 Dose 2
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 10