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The primary purpose of the study is to evaluate the safety and tolerability following multiple ascending doses of E2086 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Cohort 1: E2086 Dose 1 or Placebo | Experimental | Healthy participants will receive E2086 Dose 1 or two E2086 matched placebo, tablets, orally, once daily after an overnight fast of 10 hours. |
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| Part A, Cohort 2: E2086 Dose 2 or Placebo | Experimental | Healthy participants will receive E2086 Dose 2 or one E2086 matched placebo, tablets, orally, once daily after an overnight fast of 10 hours. |
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| Part A, Cohort 3: E2086 Dose 3 or Placebo | Experimental | Healthy participants will receive E2086 Dose 3 or two E2086 matched placebo, tablets, orally, once daily after an overnight fast of 10 hours. |
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| Part B: E2086 Dose 2 Fasted + E2086 Dose 2 Fed | Experimental | Healthy participants will receive E2086 Dose 2, tablets, orally, once on Day 1 of Treatment Period 1 in fasted state, followed by E2086 Dose 2, tablets, orally, once on Day 4 of Treatment Period 2 in fed state. |
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| Part B: E2086 Dose 2 Fed + E2086 Dose 2 Fasted | Experimental | Healthy participants will receive E2086 Dose 2, tablets, orally, once on Day 1 of Treatment Period 1 in fed state, followed by E2086 Dose 2, tablets, orally, once on Day 4 of Treatment Period 2 in fasted state. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2086 | Drug | E2086 tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International | Glendale | California | 91206 | United States |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Part A is a parallel design and Part B is a crossover design.
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Part A is double-blind and Part B is open-label.
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| Placebo | Drug | E2086 matched placebo tablets. |
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| 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 |
| 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 |