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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT04547361

Run by

Eisai Inc.

People needed

45

Starts

2020-09-14

Expected to finish

2021-05-26

Last updated by the study team

2021-07-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Non-smoking, age greater than or equal to (>=) 18 years and less than (<) 55 years old adult male or female (Cohorts 1 - 6) or age >=65 years and less than or equal to (<=) 85 years old elderly male or female (Cohort 7) at the time of informed consent
• Weight of at least 50 kilogram (kg) and body mass index >=18 and <30 kilogram per square meter (kg/m\^2) at Screening

You may not qualify if…

• Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria (that is, not of childbearing potential or practicing highly effective contraception throughout the study period plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period plus 90 days after discharge from the study.
• Females who are breastfeeding or pregnant at Screening or Baseline
• Females of childbearing potential who:
• Within 28 days before study entry, did not use a highly effective method of contraception,
• Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation.
• Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
• Evidence of disease that may influence the outcome of the study within 4 weeks before dosing
• Evidence of disease related to chronic headaches, migraines, joint pain or other disorders or disease resulting in chronic or intermittent pain within 4 weeks before dosing
• Any personal or family history of seizures (including febrile seizures) or diagnosis of epilepsy or episode of unexplained loss of consciousness
• Any history of neurological or other medical conditions which in the opinion of the investigator has the potential to reduce seizure threshold
• Any epileptiform discharges in EEG at Screening
• A prolonged QT/ QT interval corrected for heart rate (QTc) interval >450 millisecond [ms]) A history of risk factors for torsade de pointes
• History of prolonged QT/QTc interval
• Left bundle branch block
• History of myocardial infarction or active ischemic heart disease
• History of clinically significant arrhythmia or uncontrolled arrhythmia
• Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the C-SSRS
• Any lifetime history of psychiatric disease

Where it is running

• Worldwide Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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