Study Summary
This trial tests a new drug for safety and how well it's tolerated in healthy adults and seniors.
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1
Study Objectives
9 Primary · 15 Secondary · Reporting Duration: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Day 1
Ae: Cumulative Amount of E2086 and its Metabolites Excreted in Urine
CLR: Renal Clearance of E2086 and its Metabolites
Fe: Percent (%) of E2086 and its Metabolites Excreted in Urine
MRU: Ratio of Ae Urine Concentration of Metabolite to E2082, Corrected for Molecular Weights
Day 1
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite for E2086 and its Metabolites
AUC(0-t): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for E2086 and its Metabolites
CL/F: Apparent Total Clearance for E2086
Cmax: Maximum Observed Plasma Concentration for E2086 and its Metabolites
MRp: Ratio of Plasma AUC(0-inf) of Metabolite to E2082, Corrected for Molecular Weights
Tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) for E2086 and its Metabolites
Vz/F: Apparent Volume of Distribution at Terminal Phase for E2086
t1/2: Terminal Elimination Phase Half-life for E2086 and its Metabolites
Day 1
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for E2086 and its Metabolites
Day 1
AUC(0-72h): Area Under the Plasma Concentration-time Curve From Time Zero to 72 hours Post-dose for E2086 and its Metabolites
Day 10
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Number of Participants With Clinically Significant Abnormal Laboratory Values
Number of Participants With Clinically Significant Abnormal Neurological Examination Findings
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Number of Participants With Clinically Significant Abnormal Vital Signs Values
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Day 5
Mean Change in Subjective Sleep Onset Latency (sSOL)
Day 1
Number of Participants With Clinically Significant Abnormal Electroencephalogram (EEG) Findings
Trial Safety
Phase-Based Safety
Trial Design
8 Treatment Groups
Part A, Cohort 4: E2086 10 mg or Placebo
1 of 8
Part B, Cohort 8: E2086 25 mg or Placebo
1 of 8
Part A, Cohort 6: E2086 50 mg or Placebo
1 of 8
Part A, Cohort 2: E2086 2.5 mg or Placebo
1 of 8
Part A, Cohort 3: E2086 5 mg or Placebo
1 of 8
Part A, Cohort 7: E2086 100 mg or Placebo
1 of 8
Part A, Cohort 1: E2086 1 mg or Placebo
1 of 8
Part A, Cohort 5: E2086 25 mg or Placebo
1 of 8
Experimental Treatment
64 Total Participants · 8 Treatment Groups
Primary Treatment: Treatment · Has Placebo Group · Phase 1
Part A, Cohort 4: E2086 10 mg or PlaceboExperimental Group · 2 Interventions: Placebo, E2086 · Intervention Types: Drug, Drug
Part B, Cohort 8: E2086 25 mg or PlaceboExperimental Group · 2 Interventions: Placebo, E2086 · Intervention Types: Drug, Drug
Part A, Cohort 6: E2086 50 mg or PlaceboExperimental Group · 2 Interventions: Placebo, E2086 · Intervention Types: Drug, Drug
Part A, Cohort 2: E2086 2.5 mg or PlaceboExperimental Group · 2 Interventions: Placebo, E2086 · Intervention Types: Drug, Drug
Part A, Cohort 3: E2086 5 mg or PlaceboExperimental Group · 2 Interventions: Placebo, E2086 · Intervention Types: Drug, Drug
Part A, Cohort 7: E2086 100 mg or PlaceboExperimental Group · 2 Interventions: Placebo, E2086 · Intervention Types: Drug, Drug
Part A, Cohort 1: E2086 1 mg or PlaceboExperimental Group · 2 Interventions: Placebo, E2086 · Intervention Types: Drug, Drug
Part A, Cohort 5: E2086 25 mg or PlaceboExperimental Group · 2 Interventions: Placebo, E2086 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1: pre-dose (0 hour) up to 216 hours post-dose
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
511 Previous Clinical Trials
151,633 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your body mass index (BMI) is between 18 and 30 kg/m^2.