The primary purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending oral doses of E6742 in Japanese healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
24
Eisai Trial Site #1
Bunkyō-Ku, Tokyo, Japan
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs; laboratory evaluation for hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and the performance of physical examinations.
Time frame: Baseline up to 28 days after the last dose of study drug (approximately Day 35)
Cmax: Maximum Observed Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Day 1
Time frame: Day 1: 0-12 hours
tmax: Time at Which the Highest Drug Plasma Concentration Occurs for E6742 and its Metabolite (ER-001132963) on Day 1
Time frame: Day 1: 0-12 hours
AUC(0-12h): Area Under the Plasma Concentration-time Curve From Zero Time to 12 Hours Postdose for E6742 and its Metabolite (ER-001132963) on Day 1
Time frame: Day 1: 0-12 hours
AUC Metabolite to E6742 Ratio Following Molecular Weight Correction to E6742 Equivalents on Day 1
Time frame: Day 1: 0-12 hours
Css,max: Maximum Observed Plasma Concentration at Steady State for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: Day 7: 0-168 hours
tss,max: Time at Which the Highest Drug Plasma Concentration Occurs at Steady State for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: Day 7: 0-168 hours
Css,av: Average Steady State Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: Day 7: 0-168 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: Day 7: 0-168 hours
AUC(0-12hr): Area Under the Plasma Concentration-time Curve Within a Dosing Interval at Steady State for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: Day 7: 0-12 hours
t1/2: Terminal Elimination Phase Half-life for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: Day 7: 0-168 hours
CLss/F: Apparent Total Clearance at Steady State for E6742 on Day 7
Time frame: Day 7: 0-168 hours
Vss/F: Apparent Volume of Distribution at Steady State for E6742 on Day 7
Time frame: Day 7: 0-168 hours
PTF: Peak-trough Fluctuation for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: Day 7: 0-168 hours
Accumulation Ratio for Cmax and AUC for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: Day 7: 0-168 hours
Metabolite to E6742 AUC Ratio Following Molecular Weight Correction to E6742 Equivalents on Day 7
Time frame: Day 7: 0-168 hours
AUC(0-12hr)ss: Area Under the Plasma Concentration-time Curve Within a Dosing Interval at Steady State for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: Day 7: 0-12 hours
Change From Baseline in Corrected QT Interval (QTc) for E6742
High precision method QT analysis (HPQT) will be performed using data extracted from the 12-hour holter recording obtained from the morning of day 1 (predose) through 12 hours after dosing, the morning of day 7 (predose) through 12 hours after dosing.
Time frame: Day 1 and 7: 0-12 hours