Constipation Predominant Irritable Bowel Syndrome MedDRA version: 12.1 Level: LLT Classification code 10066868 Term: Constipation predominant irritable bowel syndrome
Conditions
Interventions
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: e
Sponsors
Targacept Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: History of or current clinically significant medical illness, other than IBS-C, including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, untreated thyroid disease, glaucoma, neurologic or psychiatric disease, or infection; Subjects with diarrhea predominant irritable bowel syndrome (IBS-D), or alternating irritable bowel syndrome (IBS-A); Subjects with evidence of structural abnormality of the gastrointestinal tract or diseases or conditions (other than IBS-C) that affect bowel transit; Subjects with a history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Odii dysfunction, or abdominal adhesions; Subjects with evidence of cathartic colon or who admit to a history of laxative abuse; Subjects with clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission; Subjects with a clinically significant abnomal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening or admission; Subjects with a history or presence of gastrointestinal (other than IBS-C), hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs; Use of any prescription or nonprescription medication to treat IBS-C, including use of laxatives or lubiprostone (stable use of fiber supplements is allowed); Regular use of constipating medicines such as opioids or anticholinergic/antimuscarinic agents; Use of antacids, H2 blockers or protein pump inhibitors; Use of nicotine-containing substances, including tobacco products like cigarrettes, cigars, chewing tobacco, gum, patch, throughout the study duration and within the previous 6 months; Subjects with a history of or suspected history of drug or alcohol abuse (regular alcohol consumption in males >21 units per week and females >14 units per week) within the past 5 years; Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates at screening or on admission on Day -1; Subjects with a history of clinically significant drug (or other) allergy; Subject with donated blood or blood products or had substantial loss of blood (more than 50mL) within 3 months of first administration of study drug, or subjects with intention to donate blood or blood products during the study or within 1 month after the completion of the study; Subjects who received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half life, before the first dose of the study drug is scheduled; Subjects with a known history of infection with human immunodeficiency virus (HIV) or viral hepatitis; Subjects with preplanned surgery or procedures (including dental care) during the study period that would interefere with the conduct of the study; An employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, as well as family members of the employees or the investigator; Subjects unlikely to cooperate in the study, and/or where poor compliance with the study prohibitions and restrictions is anticipated by the investigator; Subjects with no legal cap
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;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.;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. | — |
Countries
United Kingdom
Outcome results
None listed