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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have been born in Japan of Japanese parents and Japanese grandparents
Must have lived no more than 5 years outside of Japan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: pre-dose up to 24 hours post-dose; day 14: pre-dose up to 24 hours post-dose
Awards & highlights
Study Summary
The primary objective of this study is to evaluate the safety, tolerability, and plasma pharmacokinetic (PK) of E2511 following multiple oral doses in healthy adult participants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are male or female, non-Japanese, and you are aged at least 18 years
Select...
You are not living outside of Japan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1: pre-dose up to 24 hours post-dose; day 14: pre-dose up to 24 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: pre-dose up to 24 hours post-dose; day 14: pre-dose up to 24 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for E2511
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite for E2511
AUC(0-t): Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for E2511
+22 moreSecondary outcome measures
Change From Baseline in Heart Rate (HR)
Change From Baseline in PR Interval of the ECG (PR), QRS Interval of the ECG (QRS), and QT Interval Corrected for Heart Rate (QTc) of the ECG
Change From Baseline in the Concentration of Acetylcholine (ACh) in Cerebrospinal Fluid (CSF)
+18 moreTrial 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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
154,052 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
California Clinical Trials Medical Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
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