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

Targacept

Status and phase

Completed

Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Placebo

Drug: TC-6499

Study type

Interventional

Funder types

Industry

Identifiers

NCT01149200

TC-6499-12-CLP-004

Details and patient eligibility

About

Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant IBS patients over a 28-day period.

Full description

This is a randomized, double blind, placebo controlled study of a maximum of 24 subjects with constipation predominant irritable bowel syndrome (IBS-C). Sixteen subjects will receive active treatment and 8 subjects will receive matching placebo. There will be a 21-day screening phase before 1st study drug administration on Day 1.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.