California Clinical Trials Medical Group
Glendale, California, 91206, United States
NCT Number: NCT05147337
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 1
Glendale, California, 91206, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
E2511 tablets.
E2511 matched placebo tablets.
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
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.
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Time frame: From Screening up to 14 days after the last dose of study drug (up to 56 days)
Time frame: Day 1: pre-dose up to 24 hours post-dose
Time frame: Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose
Time frame: Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose
Time frame: Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 14: pre-dose up to 24 hours post-dose
Time frame: Baseline, Day 13
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Up to Day 15
The blood pressure (BP) will be evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the measurement of BP recordings after every 24 hours.
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Up to Day 15
The BP will be evaluated by ABPM for all participants based on the measurement of BP recordings after every 24 hours.
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Baseline up to Day 15
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Time frame: Day 1: pre-dose up to 24 hours post-dose; Day 14: pre-dose up to 24 hours post-dose
Eisai Inc.
Industry
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Healthy Adult and Elderly Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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