NCT02268838

Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects

A Phase 1 Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study. This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and 400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single dose of the study drug under fasted condition. Following 3 days of washout period, subject will receive the study drug once daily for 7 days starting on the fifth day from the single dose administration. For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed condition, to evaluate food effect of the study drug.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	E6007
DRUG	E6007 matching placebo

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-07-01
• Completion: 2015-11-01
• First posted: 2014-10-20
• Last updated: 2016-01-20

Locations

1 site across 1 country: Japan