Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers
Condition: Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Intervention: Dolcanatide; Laboratory Biomarker Analysis; Placebo Administration; Questionnaire Administration
Intervention description: Given PO; Correlative studies; Given PO; Ancillary studies
Intervention MeSH terms: Dolcanatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase I trial studies how well dolcanatide works in preventing colorectal cancer in
      healthy participants. Dolcanatide is similar to a natural hormone released into the
      intestine. It is thought that people who have low levels of the hormone are more likely to
      get colon cancer. It may be possible to prevent colon cancer by giving a drug that is similar
      to the hormone, such as dolcanatide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PRE-REGISTRATION INCLUSION

          -  Able to understand and willingness to sign a written informed consent document and
             follow study procedures

          -  Willing to abstain from grapefruit juice during study

          -  Willing to employ adequate contraception for men and women of childbearing potential;
             Note: acceptable methods include double barrier methods, intrauterine device (IUD),
             postmenopausal status documented by serum follicle stimulating hormone (FSH), and/or
             documentation of surgical sterilization

          -  Willing to provide blood and tissue specimens for research purposes

          -  REGISTRATION INCLUSION

          -  Normal organ function and have normal laboratory findings without clinically
             significant findings

          -  Leukocytes >= 3 x 10^3/microliter (B/L)

          -  Absolute neutrophil count >= 1.5 x 10^3/microliter (B/L)

          -  Platelets >= 100 x 10^3/microliter (B/L)

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/
             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x
             institutional upper limit of normal (ULN)

          -  Creatinine =< institutional upper limit of normal

          -  Body mass index < 35 kg/m^2

          -  No findings in the rectum of advanced adenoma, chronic inflammation, or cancer

        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