Worldwide Clinical Trials
San Antonio, Texas, 78217, United States
NCT Number: NCT05745207
The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and elderly participants.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
San Antonio, Texas, 78217, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
E2086 tablets.
E2086 matched placebo tablets.
Time frame: From Screening up to 10 days
Time frame: From Screening up to 10 days
Time frame: From Screening up to 10 days
Time frame: From Screening up to 10 days
Time frame: From Screening up to 10 days
Time frame: From Screening up to 10 days
The C-SSRS 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 10 days
Time frame: From Screening up to 10 days
Time frame: Baseline, Days 1 and 2
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 24 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 72 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 216 hours post-dose
Time frame: Screening up to Study Day 7
sSOL is a participant-reported estimate of the amount of time (in minutes) it took the participant to fall asleep the prior evening.
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
Time frame: Day 1: Pre-dose (0 hour) up to 120 hours post-dose
Eisai Inc.
Industry
A First-In-Human, Two-Part Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 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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