Brief Summary

The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and elderly participants.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline

Completed

Started Sep 2020

Typical duration for phase_1 healthy-volunteers

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

September 7, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed

Same day until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2021

Completed

Last Updated

July 12, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

September 7, 2020

Last Update Submit

July 7, 2021

Conditions

Healthy Volunteers

Keywords

E2511Healthy Participants

Outcome Measures

Primary Outcomes (25)

Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Markedly Abnormal Laboratory Values
From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Vital Signs Values
From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Electrocardiograms (ECGs) Findings
From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Treatment-emergent Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) 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.
From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Physical Examination Findings
From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Neurological Exam Findings
Cohorts 1, 2, 4, 5, 6, 7: Screening up to Day 1 (approximately 28 days); Cohort 3: Screening up to Day 7 (approximately 35 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Psychiatric Assessment
Number of participants with clinically significant change in psychiatric assessment will be evaluated by a psychiatrist as a measure of mental health assessment.
From screening up to 28 days after last dose of study drug (up to 63 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Number of Participants With Clinically Significant Change From Screening in Electroencephalogram (EEG) Measurements
From screening up to Day 2 (approximately 30 days)
Cohorts 1, 2, 3, 4, 5, 6, 7: Maximum Observed Plasma Concentration (Cmax) for E2511 on Day 1
Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Maximum Observed Plasma Concentration (Cmax) for E2511 on Day 7
Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Time to Reach Cmax (tmax) for E2511 on Day 1
Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Time to Reach Cmax (tmax) for E2511 on Day 7
Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Area Under the Plasma Concentration-time Curve (AUC(0-t)) From Time Zero to the Last Quantifiable Plasma Concentration for E2511 on Day 1
Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Area Under the Plasma Concentration-time Curve (AUC(0-t)) From Time Zero to the Last Quantifiable Plasma Concentration for E2511 on Day 7
Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Area Under the Plasma Concentration-time Curve (AUC(0-inf)) From Time Zero to Infinity for E2511 on Day 1
Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Area Under the Plasma Concentration-time Curve (AUC(0-inf)) From Time Zero to Infinity for E2511 on Day 7
Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Area Under the Plasma Concentration-time Curve (AUC(0-24)) From Time Zero to 24 Hours Postdose for E2511 on Day 1
Day 1: pre-dose up to a potential maximum of 24 hours post-dose
Cohort 3: Area Under the Plasma Concentration-time Curve (AUC(0-24)) From Time Zero to 24 Hours Postdose for E2511 on Day 7
Day 7: pre-dose up to a potential maximum of 24 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Terminal Elimination Phase Half-Life (t1/2) for E2511 on Day 1
Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Terminal Elimination Phase Half-Life (t1/2) for E2511 on Day 7
Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Apparent Total Clearance (CL/F) for E2511 on Day 1
Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Apparent Total Clearance (CL/F) for E2511 on Day 7
Day 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohorts 1, 2, 3, 4, 5, 6, 7: Apparent Volume of Distribution at Terminal Phase (Vz/F) for E2511 on Day 1
Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Apparent Volume of Distribution at Terminal Phase (Vz/F) for E2511 on Day 7
Day 7: pre-dose up to a potential maximum of 120 hours post-dose

Secondary Outcomes (7)

Cohort 3: Geometric Mean Ratio of Cmax Between the Fasted and Fed State for E2511 20 mg
Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Geometric Mean Ratio of AUC(0-t) Between the Fasted and fed State for E2511 20 mg
Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3: Geometric Mean Ratio of AUC(0-inf) Between the Fasted and fed State for E2511 20 mg
Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3 and Cohort 7: Geometric Mean Ratio of Cmax Between the Healthy Elderly and Adult Participants for E2511 20 mg
Cohort 3: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose; Cohort 7: Day 1: pre-dose up to a potential maximum of 120 hours post-dose
Cohort 3 and Cohort 7: Geometric Mean Ratio of AUC(0-t) Between the Healthy Elderly and Adult Participants for E2511 20 mg
Cohort 3: Days 1 and 7: pre-dose up to a potential maximum of 120 hours post-dose; Cohort 7: Day 1: pre-dose up to a potential maximum of 120 hours post-dose
+2 more secondary outcomes

Study Arms (7)

Cohort 1: Dose 1 E2511 or Placebo

EXPERIMENTAL

Participants will receive Dose 1 of E2511 or E2511 matched placebo, tablets, orally, once on Day 1 under fasted condition.