NCT03402178

Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Studies to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending oral doses of E2082 in healthy Japanese adult and elderly male participants, and to evaluate the safety, tolerability, and PK of multiple ascending oral doses of E2082 in healthy Japanese and Caucasian adult male participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	E2082	Solution (0.2 mg) or tablet (0.5 mg and 5 mg).
DRUG	Placebo	Solution (0.2 mg) or tablet (0.5 mg and 5 mg) matched to E2082.

Timeline

• Start date: 2017-12-21
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2018-01-18
• Last updated: 2021-06-30

Locations

1 site across 1 country: Japan