Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers

Exclusion Criteria

• •PRE-REGISTRATION EXCLUSION
• •Documented 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 nonpolyposis 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; exception: prior appendectomy \>= 60 days prior to pre-registration is not an exclusion criterion
• •History of celiac disease
• •Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
• •Previous diagnosis of irritable bowel syndrome, chronic constipation, functional bowel disorders, colonic motility disorder, or opioid-induced constipation
• •Any malignancy within 3 years of baseline; exception: participants with a history of basal cell or squamous cell skin cancer may be enrolled at the discretion of the investigator
• •Currently receiving any other investigational agents
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to dolcanatide or to any of the excipients
• •History of difficulty with sigmoidoscopy 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
• •Current use of laxatives more than 3 times per week
• •Current use of \>= 5 cigarettes/day
• •Current use of \>= 3 alcoholic drinks/day
• •Use of anti-coagulants or anti-platelet agents within 5 days prior to anticipated sigmoidoscopy; exception: individuals taking aspirin will not be excluded and will not be subject to a wash-out period
• •History of bleeding/coagulation problems
• •Any medical condition reported by the participant or documented in the medical record that is judged by the investigator to constitute a risk to safe participation
• •Known or suspected mechanical gastrointestinal obstruction
• •REGISTRATION EXCLUSION
• •Sigmoidoscopy finding requiring clinical intervention
• •Use of any illicit or illegal substances detected by urinary drug screen