A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Proof of Principle Study to Evaluate the Safety, Tolerability, and Efficacy of TC-6499-12 in the Treatment of Constipation Predominant Irritable Bowel Syndrome.

INTERVENTION: Product Name: TC‐6499‐12 enteric coated capsules Pharmaceutical Form: Capsule, hard INN or Proposed INN: TC‐6499 Current Sponsor code: TC‐6499 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Constipation Predominant Irritable Bowel Syndrome ; MedDRA version: 12.1 Level: LLT Classification code 10066868 Term: Constipation predominant irritable bowel syndrome PRIMARY OUTCOME: Main Objective: The principal objective is to assess the effectiveness of TC‐6499‐12 in the treatment of Constipation Predonminant Irritable Bowel Syndrome (IBS‐C). Primary end point(s): The primary evaluation of the effectiveness of TC‐6499‐12 will be the assessment of the global symptom relief question on study Day 29: "How would you rate your relief of IBS symptoms (abdominal discomfort/pain, bowel habits, and other IBS symptoms) over the past week compared to how you felt before you entered the study?"; 1 ‐ much worse; 2 ‐ worse; 3 ‐ slightly worse; 4 ‐ the same; 5 ‐ slightly better; 6 ‐ better; 7 ‐ much better; Scores for the global symptom relief questionnaire will be plotted by visit and treatment. Secondary Objective: The secondary research objectives are to assess the safety, tolerability and drug absorption profile of TC‐6499‐12 in subjects with IBS‐C when given as a capsule designed to bypass the stomach. INCLUSION CRITERIA: Male subjects aged 18‐65 and Females between 18 to 65 years of age, inclusive Females of child‐bearing potential i.e. females not documented surgical sterilization or at least 1 year post last menses, verified with elevated levels of FSH/LH must have a negative pregnancy test at baseline (screening and pre‐dose Day 1) and must comply with the contraceptive advice given. In addition these females must also have had a confirmed menstrual period (as defined by first day of menses) within 12 days of first dosing day Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range