NCT02902978

A Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects

A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: EA Pharma Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.

Detailed description

This study consists of 8 cohorts, Cohorts 1 to 8. Cohorts 1 to 7 are designed as a single-center, single dose, placebo-controlled, randomized, ascending dose, double-blind study. Cohort 8 is designed as a single-center, single dose, randomized, open-label, two-group, two-period crossover study. Cohort 8 will be initiated after Cohorts 1 to 7 are completed.

Conditions

• Japanese Healthy Adult Male Participants

Interventions

Type	Name	Description
DRUG	E6130
DRUG	Placebo	E6130 matched placebo

Timeline

• Start date: 2016-09-26
• Primary completion: 2017-08-17
• Completion: 2017-08-17
• First posted: 2016-09-16
• Last updated: 2018-09-06

Locations

1 site across 1 country: Japan