Status:
COMPLETED
Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 th...
Detailed Description
PRIMARY OBJECTIVES: I. To identify the ability of dolcanatide (SP333), when administered as a single daily dose of 27 mg x 7 days, to induce a direct pharmacological effect on cGMP levels, based on b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03300570
Start Date
July 27 2018
End Date
May 17 2021
Last Update
June 14 2021
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107