A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects
| Status: | Archived |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2010 |
| End Date: | September 2011 |
The purpose of this study is to evaluate the safety and tolerability of single oral
ascending doses of E6007 in healthy subjects.
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.
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