The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E8001 of single ascending dose intravenous infusions in healthy male participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
36
Eisai Trial Site #1
Minatoku, Japan
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs; regular monitoring of clinical laboratory parameters; and periodic measurement of vital signs and 12-lead electrocardiogram (ECG), body weight and physical examinations.
Time frame: Screening up to Day 180 (approximately 292 days)
Cmax: Maximum Observed Plasma Concentration for E8001
Time frame: Day 1: 0-168 hours
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E8001
Time frame: Day 1: 0-168 hours
AUC(0-t): Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E8001
Time frame: Day 1: 0-168 hours
T1/2: Terminal Elimination Phase Half-life for E8001
Time frame: Day 1: 0-168 hours
CL: Total Clearance for E8001
Time frame: Day 1: 0-168 hours
Vss: Volume of Distribution at Steady State for E8001
Time frame: Day 1: 0-168 hours
Change From Baseline in Corrected QT (QTc) Interval
To assess the effect of E8001 on ventricular repolarization by assessing the QTc interval corrected by the Fridericia formula (QTcF).
Time frame: Day 1: 0-24 hours
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