Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers

This is an interventional basic science trial for Colorectal Cancer Read More

Inclusion Criteria:

• PRE-REGISTRATION INCLUSION CRITERIA
• Ability to understand and willingness to sign a written informed consent document and follow study procedures
• Willingness to abstain from grapefruit juice, alcohol, and concomitant medications during study
• Willingness to employ adequate contraception for men and women of childbearing potential; acceptable methods include double barrier methods, intrauterine device (IUD), postmenopausal status documented by serum follicle-stimulating hormone (FSH), and/or documentation of surgical sterilization
• Body mass index < 35 kg/m^2
• Willingness to provide blood and tissue specimens for research purposes
• REGISTRATION INCLUSION CRITERIA
• Participants must have normal organ function and have normal laboratory findings without clinically significant findings
• Satisfactory anesthesia and intestinal preparation, with no findings of advanced adenoma, chronic inflammation, or cancer

Exclusion Criteria:

• PRE-REGISTRATION EXCLUSION CRITERIA
• Previous personal history of advanced adenomas (>= 1 cm in maximal diameter, >= 3 in total number, villous morphology, or high-grade dysplasia) or colorectal cancer
• Family history of polyposis syndrome (e.g., familial adenomatous polyposis [FAP], hereditary non-polyposis colorectal cancer [HNPCC]) or colorectal cancer (first degree relatives younger than 60 years old)
• History of gastroparesis
• History of surgery involving the luminal gastrointestinal (GI) tract, including bariatric surgery
• History of celiac disease
• Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
• Irritable bowel syndrome, chronic constipation, functional bowel disorders, or colonic motility disorder
• Any malignancy within 3 years of baseline; participants with a history of basal cell or squamous cell skin cancer may be enrolled at the discretion of the investigator
• Participants may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to linaclotide
• History of difficulty with colonoscopy or abnormal colorectal anatomy
• Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or lactating women
• Use of laxatives more than 3 times per week
• Intestinal motility agents, histamine-2 inverse agonists (H-2 blockers), or proton pump inhibitors
• Current use of >= 5 cigarettes/day
• Current use of >= 3 alcoholic drinks/day
• Use anti-platelet agents within two weeks of anticipated colonoscopy
• Use of anti-coagulants within two weeks of anticipated colonoscopy
• History of bleeding/coagulation problems
• Prior intolerance of or contraindications for the use of sedation or anesthetic agents, which would prevent the safe use of sedation for colonoscopy; this includes allergies to eggs and soy products
• Any medical condition judged by the investigator to constitute a risk to safe participation
• REGISTRATION EXCLUSION CRITERIA
• Colonoscopic finding requiring clinical intervention
• Use of any illicit or illegal substances detected by urinary drug screen
• Inadequate pre-intervention bowel preparation, as determined by the study physician