NCT01221818

A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of single oral ascending doses of E6007 in healthy subjects.

Detailed description

This is a randomized, double-blind, placebo-controlled, ascending single dose study to evaluate the safety and tolerability of E6007 in healthy subjects. Six dose groups will be evaluated. Subjects will receive either 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, or 600 mg E6007 or matching placebo tablets. Subjects will undergo screening evaluations, baseline evaluations, Day 1 (dosing day), and Days 2-5 evaluations. They will also have a follow-up visit on Day 90 and a Day 180 follow-up phone call.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	E6007	E6007 25mg single dose or matching placebo
DRUG	E6007	E6007 50mg single dose or matching placebo
DRUG	E6007	E6007 100mg single dose or matching placebo
DRUG	E6007	E6007 200mg single dose or matching placebo
DRUG	E6007	E6007 400mg single dose or matching placebo
DRUG	E6007	E6007 600 mg single dose or matching placebo

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-10-01
• First posted: 2010-10-15
• Last updated: 2014-07-11

Locations

1 site across 1 country: United States