Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers (NCT01950403) | Clinical Trial Compass
CompletedPhase 1
Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers
United States24 participantsStarted 2013-09
Plain-language summary
This randomized phase I trial studies the side effects and best dose of linaclotide acetate in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal cancer.
Who can participate
Age range18 Years ā 65 Years
SexALL
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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, includingā¦
What they're measuring
1
Dose of linaclotide acetate that produces a 60% response rate for cGMP levels in rectal tissue by radioimmunoassay (RIA)