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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
32
E2730 capsules.
E2730-matched placebo capsules.
Collaborative Neuroscience Research, LLC.
Long Beach, California, United States
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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: Screening up to Day 32 (approximately 60 days)
Part A, Cmax: Maximum Observed Plasma Concentration for E2730
Time frame: Day 1: 0-24 hours; Day 18: 0-336 hours
Part A, Css,min: Minimum Observed Plasma Concentration at Steady State for E2730
Time frame: Time Frame: Day 18: 0-24 hours
Part A, tmax: Time at Which the Highest Drug Plasma Concentration Occurs for E2730
Time frame: Day 1: 0-24 hours; Day 18: 0-336 hours
Part A, Css,av: Average Steady State Plasma Concentration at Steady State for E2730
Time frame: Time Frame: Day 18: 0-24 hours
Part A, AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours After Dosing for E2730
Time frame: Day 1: 0-24 hours; Day 18: 0-24 hours
Part A, t1/2: Terminal Elimination Phase Half-life Following Last day of Dosing for E2730
Time frame: Day 18: 0-336 hours
Part A, PTF: Peak-trough Fluctuation for E2730
Time frame: Day 18: 0-24 hours
Part A, Rac: Accumulation Ratio for Cmax and AUC for E2730
Time frame: Day 1: 0-24 hours; Day 18: 0-24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Part A, CLss/F: Apparent Total Clearance Following Extravascular Administration at Steady State for E2730
Time frame: Day 18: 0-336 hours
Part A, Vz/F: Apparent Volume of Distribution at Terminal Phase
Time frame: Day 18: 0-336 hours
Part B, Cmax: Maximum Observed Plasma Concentration for E2730
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Part B, tmax: Time at Which the Highest Drug Plasma Concentration Occurs for E2730
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Part B, AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours After Dosing for E2730
Time frame: Day 1: 0-24 hours; Day 22: 0-24 hours
Part B, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E2730
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Part B, AUC(0-72h): Area Under the Plasma Concentration-time Curve From Zero Time to 72 Hours After Dosing for E2730
Time frame: Day 1: 0-72 hours; Day 22: 0-72 hours
Part B, AUC(0-inf): Area Under the Plasma Concentration-time Curve From Zero Time Extrapolated to Infinite Time for E2730
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Part B, t1/2: Terminal Elimination Phase Half-life for E2730
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Part A: Geometric Mean Ratio of Cmax Between the Healthy Japanese and non-Japanese Participants for E2730
Time frame: Day 1: 0-24 hours; Day 18: 0-336 hours
Part A: Geometric Mean Ratio of AUC(0-24) Between the Healthy Japanese and non-Japanese Participants for E2730
Time frame: Day 1: 0-24 hours; Day 18: 0-24 hours
Part B: Geometric Mean Ratio of Cmax Between the Fasted and fed State for E2730
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Part B: Geometric Mean Ratio of AUC(0-t) Between the Fasted and fed State for E2730
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Part B: Geometric Mean Ratio of AUC(0-72h) Between the Fasted and fed State for E2730
Time frame: Day 1: 0-72 hours; Day 22: 0-72 hours
Part B: Geometric Mean Ratio of AUC(0-inf) Between the Fasted and fed State for E2730
Time frame: Day 1: 0-288 hours; Day 22: 0-288 hours
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Baseline, Day 32
Change From Baseline in Heart Rate (HR)
Time frame: Baseline, Day 32
Placebo Corrected Change From Baseline in SBP and DBP
Time frame: Baseline, Day 32
Placebo Corrected Change From Baseline in HR
Time frame: Baseline, Day 32
Number of Participants With Categorical Outliers for SBP and DBP
Time frame: Baseline up to Day 32
Change From Baseline in QT Interval by Fridericia (QTcF)
Time frame: Baseline, Day 32
Change From Baseline in PR Interval of the ECG (PR), QRS Interval of the ECG (QRS)
Time frame: Baseline, Day 32
Placebo Corrected Change From Baseline in QTcF, PR and QRS
Time frame: Baseline, Day 32
Number of Participants With Categorical Outliers for QTcF, HR, PR, and QRS
Time frame: Baseline, Day 32
Number of Participants With T-wave Morphology Changes
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
Number of Participants With Presence of Abnormal U-wave
Time frame: Baseline up to Day 32