Parexel International
Glendale, California, 91206, United States
NCT Number: NCT06481488
The primary purpose of the study is to evaluate the safety and tolerability following multiple ascending doses of E2086 in healthy adult participants.
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Notify Me18 year–55 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
E2086 tablets.
E2086 matched placebo tablets.
Time frame: Day 10
Time frame: Day 10
Time frame: Day 10
Time frame: Day 10
Time frame: Day 10
Time frame: Day 8
Time frame: Day 10
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: Day 7
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: Day 1 and at steady-state
Time frame: Day 1 and at steady-state
Time frame: Day 1 and at steady-state
Time frame: Day 1
Time frame: Day 1 and at steady-state
Time frame: Day 1 and at steady-state
Time frame: Day 1
Time frame: At steady-state
Time frame: At steady-state
Time frame: At steady-state
Time frame: At steady-state
Time frame: Day 1 and at steady-state
Time frame: Day 1
Time frame: After single doses in Fasted and Fed State
Time frame: After single doses in Fasted and Fed State
Time frame: After single doses in Fasted and Fed State
Time frame: Baseline to Day 8
A central ECG laboratory will extract ECG recordings from the Holter device.
Time frame: Baseline to Day 8
A central ECG laboratory will extract ECG recordings from the Holter device.
Time frame: Baseline to Day 10
sSOL is a participant-reported parameter. Sleep onset latency is a measure of how long it takes for the participant to fall asleep once the participant gets into bed. This will be measured in minutes.
Eisai Inc.
Industry
A Randomized, Double-Blind, Placebo-Controlled, Combined Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Single Dose Study to Assess Food Effect of E2086 in Healthy Adult 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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