The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and elderly participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
53
Worldwide Clinical Trials
San Antonio, Texas, United States
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Screening up to 10 days
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Vital Signs Values
Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Time frame: From Screening up to 10 days
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: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Neurological Examination Findings
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Time frame: From Screening up to 10 days
Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings
Time frame: Baseline, Days 1 and 2
Cmax: Maximum Observed Plasma Concentration for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 24 hours post-dose
AUC(0-t): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
AUC(0-72h): Area Under the Plasma Concentration-time Curve From Time Zero to 72 hours Post-dose for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 72 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
t1/2: Terminal Elimination Phase Half-life for E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
CL/F: Apparent Total Clearance for E2086
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Vz/F: Apparent Volume of Distribution at Terminal Phase for E2086
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
MRp: Ratio of Plasma AUC(0-inf) of Metabolite to E2082, Corrected for Molecular Weights
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Mean Change in Subjective Sleep Onset Latency (sSOL)
sSOL is a participant-reported estimate of the amount of time (in minutes) it took the participant to fall asleep the prior evening.
Time frame: Screening up to Study Day 7
Ae: Cumulative Amount of E2086 and its Metabolites Excreted in Urine
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
CLR: Renal Clearance of E2086 and its Metabolites
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
Fe: Percent (%) of E2086 and its Metabolites Excreted in Urine
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
MRU: Ratio of Ae Urine Concentration of Metabolite to E2082, Corrected for Molecular Weights
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose