Eisai Trial Site #1
Minatoku, Japan
NCT Number: NCT04609852
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.
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Notify Me20 year–55 year
Male
Interventional
Phase 1
Minatoku, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous infusion.
Intravenous infusion.
Time frame: Screening up to Day 180 (approximately 292 days)
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: Day 1: 0-168 hours
Time frame: Day 1: 0-168 hours
Time frame: Day 1: 0-168 hours
Time frame: Day 1: 0-168 hours
Time frame: Day 1: 0-168 hours
Time frame: Day 1: 0-168 hours
Time frame: Day 1: 0-24 hours
To assess the effect of E8001 on ventricular repolarization by assessing the QTc interval corrected by the Fridericia formula (QTcF).
Eisai Co., Ltd.
Industry
A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E8001 in Healthy Male Subjects
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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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