Collaborative Neuroscience Research, LLC.
Long Beach, California, 90806, United States
NCT Number: NCT04676685
The primary purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E2730 of multiple ascending oral doses in healthy adult participants and to assess the differences in PK, safety, and tolerability of E2730 between healthy Japanese and non-Japanese participants following multiple doses. This study will also determine the effect of food on PK of E2730.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Long Beach, California, 90806, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
E2730 capsules.
E2730-matched placebo capsules.
Time frame: Screening up to Day 32 (approximately 60 days)
Safety assessments will consist of monitoring and recording all adverse events (AEs); laboratory evaluation for hematology, clinical chemistry, and urinalysis; periodic measurement of vital signs, electrocardiograms (ECGs), electroencephalogram (EEGs), corrected QT (QTc) interval and blood pressure.
Time frame: Day 1: 0-24 hours; Day 18: 0-336 hours
Time frame: Time Frame: Day 18: 0-24 hours
Time frame: Day 1: 0-24 hours; Day 18: 0-336 hours
Time frame: Time Frame: Day 18: 0-24 hours
Time frame: Day 1: 0-24 hours; Day 18: 0-24 hours
Time frame: Day 18: 0-336 hours
Time frame: Day 18: 0-24 hours
Time frame: Day 1: 0-24 hours; Day 18: 0-24 hours
Time frame: Day 18: 0-336 hours
Time frame: Day 18: 0-336 hours
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Time frame: Day 1: 0-24 hours; Day 22: 0-24 hours
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Time frame: Day 1: 0-72 hours; Day 22: 0-72 hours
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Time frame: Day 1: 0-24 hours; Day 18: 0-336 hours
Time frame: Day 1: 0-24 hours; Day 18: 0-24 hours
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Time frame: Day 1: 0-72 hours; Day 22: 0-72 hours
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Time frame: Baseline, Day 32
Time frame: Baseline, Day 32
Time frame: Baseline, Day 32
Time frame: Baseline, Day 32
Time frame: Baseline up to Day 32
Time frame: Baseline, Day 32
Time frame: Baseline, Day 32
Time frame: Baseline, Day 32
Time frame: Baseline, Day 32
Time frame: Baseline up to Day 32
The T-wave morphology categories includes the following: Normal T-wave (Any positive T-wave not meeting any criterion); Flat T-wave (T amplitude less than (<) 1 millimeter [mm] [either positive or negative] including flat isoelectric line); Notched T-wave (+) (Presence of notch(es) of at least 0.05 millivolt [mV] amplitude on ascending or descending arm of the positive T-wave); Biphasic (T-wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T-waves included); Normal T-wave (-) (T amplitude that is negative, without biphasic T-wave or notches); Notched T-wave (-) (Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T-wave).
Time frame: Baseline up to Day 32
Eisai Inc.
Industry
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose and Single Dose Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy 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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