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A Study to Assess the Safety and Tolerability of E2511 in Healthy Adult and Elderly Participants

Phase 1

Waitlist Available

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening up to 14 days after the last dose of study drug (up to 56 days)

Summary

This trial tests a new oral drug called E2511 in healthy adults to see how it moves through the body and if it is safe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening up to 14 days after the last dose of study drug (up to 56 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening up to 14 days after the last dose of study drug (up to 56 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to 14 days after the last dose of study drug (up to 56 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-suicide Severity Rating Scale (C-SSRS)

Secondary study objectives

Mean Change From Baseline in 24-hours Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) up to Day 15

Placebo Corrected Mean Change From Baseline in 24-hours SBP and DBP up to Day 15

Trial Design

8Treatment groups

Experimental Treatment

Group I: Cohort 8: E2511 40 mg or PlaceboExperimental Treatment2 Interventions

Non-Japanese older (\>=55 years and less than or equal to \[\<=\] 85 years old) participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.

Group II: Cohort 7: E2511 80 mg or PlaceboExperimental Treatment2 Interventions

Japanese adult participants will receive 80 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.

Group III: Cohort 6: E2511 40 mg or PlaceboExperimental Treatment2 Interventions

Japanese adult participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.

Group IV: Cohort 5: E2511 20 mg or PlaceboExperimental Treatment2 Interventions

Japanese adult (\>=20 years and \<55 years old) participants will receive 20 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.

Group V: Cohort 4: E2511 80 mg or PlaceboExperimental Treatment2 Interventions

Non-Japanese adult participants will receive 80 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.

Group VI: Cohort 3: E2511 40 mg or PlaceboExperimental Treatment2 Interventions

Non-Japanese adult participants will receive 40 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.

Group VII: Cohort 2: E2511 20 mg or PlaceboExperimental Treatment2 Interventions

Non-Japanese adult participants will receive 20 mg E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.

Group VIII: Cohort 1: E2511 10 mg or PlaceboExperimental Treatment2 Interventions

Non-Japanese adult (greater than or equal to \[\>=\] 18 years and less than \[\<\] 55 years old) participants will receive 10 milligram (mg) E2511 or E2511 matched placebo, tablets, orally, once daily from Day 1 to Day 14.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

E2511

2020

Completed Phase 1

~100

Placebo

1995

Completed Phase 3

~2670