Overview

Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
Summary
Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant IBS patients over a 28-day period.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Targacept Inc.
Criteria
Inclusion Criteria:

- Men with IBS-C (ROME III) between 18 and 65 years of age, inclusive.

- Women with IBS-C (ROME III) between 55 and 65 years of age, or 18 to 55 years of age
with documentation of non-childbearing potential status (surgical sterilization or one
year post last menses with elevated FSH/LV).

- All subjects should have a body mass index (BMI) between 18 and 34 kg/m2, inclusive
and a body weight of not less than 45 kg.