A Phase 1 interventional study of E8001 and Placebo in Healthy Volunteers, sponsored by Eisai Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Eisai Co., Ltd. · Phase 1, Interventional, and Other
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.
Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Liver function test with following values at Screening or Baseline:
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Drug: E8001 · Drug: Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Drug: E8001 · Drug: Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Drug: E8001 · Drug: Placebo
Participants will receive specified dose of E8001 or placebo (isotonic sodium chloride solution), infusion, intravenously, once on Day 1.
Drug: E8001 · Drug: Placebo
Intravenous infusion.
Intravenous infusion.
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
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Eisai Co., Ltd.